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: For starters, what is the minimalist approach to transcatether aortic valve implantation (TAVI)?
ANSWER: Minimalist TAVI is a recent strategy to simplify the procedure, reduce possible complications, and favor early hospital discharges. This general definition can be explained by 2 keys aspects: what measures should be taken? And what patients should be eligible? Replacing general anesthesia and orotracheal intubation for sedation and local anesthesia are some of these measures. Sedation with the use of a laryngeal mask airway waking up the patient once the procedure is done is an intermediate situation. The type of hospital stay following TAVI is also an important aspect to be considered and it is associated with the type of anesthesia or sedation used: intensive care unit, post-anesthesia care unit or the hospital cardiac care unit. Other minimalist approaches during the procedure would be the access site used and the percutaneous closure, to avoid bladder catheterization, use the femoral venous access, use the radial, and not the femoral, artery for monitorization purposes, and to avoid the transesophageal echocardiogram. After the implantation, promoting early walking and removing IVs as soon as possible may also help. All these measures facilitate early hospital discharges. However, the hospital stays following these minimalist measures vary in the series published. In the first series ever published,1 the average stay was 3 days including the intensive care unit stay. Recent series2 report next-day hospital discharges for patients without complications within the first 24 hours. Finally, in the pandemic era of COVID-19 even same-day hospital discharges have sometimes been proposed.3
The other key aspect we should analyze is what patients should be eligible for minimalist TAVI, something we will talk about later.
Q.: What advantages does general anesthesia have to offer and what is patient profile is the most eligible of all?
A.: The way I see it, general anesthesia is beneficial for 2 reasons mainly. The first one is that the patient will remain still for the entire procedure, which is very convenient because precision is required when moving and placing the catheters. The second one is that, in case of hemodynamic instability or serious complications, we have one healthcare professional available, the anesthesiologist, in charge of the patient’s ventilation and vital signs. This liberates the operator who can devote himself to the implantation technique alone or to solve any of the complications that may have occurred. Still, some issues still need further clarification: first, the difference between general anesthesia and sedation. In non-intubated patients, superficial general anesthesia or deep sedation can be used. These are very similar techniques with some very similar aspects that overlap. The use of the laryngeal mask airway provides versatility to adequate sedation or anesthesia for each case in particular. The anesthesiologist is free to use the technique he likes the most with one condition only, that the patient needs to «come in awake and leave the same way». Most times, laryngeal mask airways are used. They are often removed after implantation to refer the patient to the post-anesthesia care unit while awake and with spontaneous breathing. He will remain in this unit for 2 to 4 hours. Then, he will be transferred to the hospital cardiac care unit for electrocardiographic monitoring. The second aspect to be considered is the availability of the anesthesiologist. Sedation without anesthesia gives more versatility while setting everything up at the cath lab and facilitates the performance of more TAVIs regardless of the anesthesiologist’s days available. However, the drawback is that sedation is not that perfect and, in case of hemodynamic instability during the procedure, the operators will have to do 2 things: stabilize the situation, and then proceed with the implantation. Our experience is that having an anesthesiologist available is beneficial because he can provide «a la carte» sedation or anesthesia without extending the hospital stay. Also, the patient is back to the hospital cardiac care unit within a few hours.
Q.: Do you think the transesophageal echocardiography (TEE) brings added value to TAVI? In what cases would it be more indicated during the procedure?
A.: TEE was often used when this technique was born to measure the aortic annulus when the process of sizing the valve was not as standardized as it is today. The computed tomography analyzed by current software provides all kinds of measurements including diameters, perimeters, and areas allowing an accurate selection of the device and leaving the indication for TEE obsolete. Another utility of TEE during the procedure is for the early detection of complications. In patients with severe hemodynamic impairment, it facilitates the differential diagnosis of the complication immediately. Therefore, cardiac tamponade, severe ventricular dysfunction, and severe mitral or aortic regurgitation can be identified early, which in turn facilitates the rapid adoption of the necessary measures. Thrombi and aortic damage are other complications that can also be detected with this imaging modality. To this date, except for the early detection of complications, the TEE does not seem of great utility during the procedure. Since complications are rare and difficult to predict, the systematic use of TEE has been losing interest. This, added to the requirement for endotracheal intubation and longer procedural and hospital stay times4 has put its elective use to an end in most cath labs. The transthoracic echocardiography provides enough information for the decision-making process. Also, in selected cases informs of major complications like severe mitral regurgitation or aortic annulus rupture, the TEE can be used.
Q.: Vascular occlusion systems have variable, yet constant, rates of failure and complications. Do you think there are still indications for minimal access surgery? Where does your heart team stand regarding valvular accesses?
A.: I think there are no indications for minimal access surgery regarding the femoral access. Computed tomography or ultrasound-guided punctures are often used as well as percutaneous closures. Although the latter have some rate of failure, covered stent implantation from the contralateral femoral region would solve most vascular access problems. Femoral surgery is often spared for catastrophic situations only when the problem simply cannot be solved percutaneously. Therefore, from 2019 to this date, 32 failures (13%) have been reported from of a total of 239 cases regarding closures with the suture device that resolved after covered stent implantation from the contralateral femoral region. Also, only in 1 case (0.4%) emergency surgery was required. If possible, our option should always be the femoral access that, as I already said, has always been percutaneous. Elective minimal access surgery has only been used in other access routes different from the femoral one; in our own experience, it has been the subclavian access in patients with severe disease at the femoral iliac territory. Although the percutaneous approach has been described through this access route,5 we are not as experienced with it since most TAVIs can be performed percutaneously via femoral access. Other access routes that require surgery are the transcarotid and the transaortic ones, but we don’t have any experience at all here.
Q.: Regarding patients discharged after TAVI, what is the common practice at your center and what would you recommend?
A.: Ambulatory care patients without femoral complications or conduction disorders find themselves walking the next day. A transthoracic echocardiography is performed after 24-48 hours, and they are often discharged after 2 days. The causes that can delay hospital discharge are severe heart failure prior to TAVI, access site complications (whether homolateral or contralateral), the presence of fever, kidney failure, and conduction disorders. In the latter, delaying the hospital discharge is due to the decision on whether to implant a definitive pacemaker or keep the patient hospitalized while waiting for a definitive resolution of the possible intermittent disorders. A panel of experts has proposed 5 different algorithms depending on the type of conduction defect reported in baseline conditions and after the procedure.6 The goal is to standardize both the indications for definitive pacemaker implantation and the monitorization time necessary for the decision-making process. Thus, the decision to implant a definitive pacemaker cannot be made within the first 24-hours in most patients. My recommendation on hospital discharge following TAVI is to simplify procedure and convalescence as much as possible and try hospital discharge after 48 hours. When the aforementioned complications occur, the right thing to do is wait until they are solved. The algorithms mentioned6 are useful to make the decision, as soon as possible, on whether to implant a definitive pacemaker or not.
Q.: Finally, in your own opinion, what patients would be eligible for minimalist TAVI and when is it ill-advised?
A.: Although the Vancouver 3M7 criteria are wide enough to include patients in the minimalist approach to TAVI I think it should only be eligible for patients scheduled for TAVI without severe heart failure with good femoral access, no kidney failure or respiratory failure or anemia. However, it would be ill-advised in hospitalized patients with heart failure and hemodynamic instability, depressed ejection fraction or who don’t meet the aforementioned criteria. In patients with previous conduction disorders, the algorithms proposed by the panel of experts should be followed.6 As I have already said, in the presence of complications, the minimal approach to TAVI strategy should be changed and hospital discharged delayed until the complication has resolved, and the patient has fully recovered. In this context, as Albert Einstein used to say: «everything should be made as simple as possible, but no simpler».
FUNDING
None reported.
CONFLICTS OF INTEREST
None reported.
REFERENCES
1. Babaliaros V, Devireddy C, Lerakis S, et al. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach):outcomes and cost analysis. JACC Cardiovasc Interv. 2014;7:898-904.
2. Kamioka N, Wells J, Keegan P, et al. Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018;11:107-115.
3. Perdoncin E, Greenbaum AB, Grubb KJ, et al. Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era. Catheter Cardiovasc Interv. 2021;97:940-947.
4. Bhatnagar UB, Gedela M, Sethi P, et al. Outcomes and Safety of Transcatheter Aortic Valve Implantation With and Without Routine Use of Transesophageal Echocardiography. Am J Cardiol. 2018;122:1210-1214.
5. Amat-Santos IJ, Santos-Martínez S, Conradi L, et al. Transaxillary transcatheter ACURATE neo aortic valve implantation —The TRANSAX multicenter study. Catheter Cardiovasc Interv. 2020. https://doi.org/10.1002/ccd.29423.
6. Rodés-Cabau J, Ellenbogen KA, Krahn AD, et al. Management of Conduction Disturbances Associated With Transcatheter Aortic Valve Replacement:JACC Scientific Expert Panel. J Am Coll Cardiol. 2019;74:1086-1106.
7. Wood DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers:The 3M TAVR Study. JACC Cardiovasc Interv. 2019;12:459-469.
QUESTION: What is the current status of percutaneous coronary interventions to treat functional mitral regurgitation (MR)?
ANSWER: Functional MR is one of the clinical conditions within cardiology that have experienced more changes over the last few years. Currently, not only the best way to treat it is under study including contributions from percutaneous techniques, but also its very definition is under review. Initially, cut-off values used to be selected to define its severity that were different from those of primary MR based on the results from longitudinal studies in populations that had suffered myocardial infarctions.1 However, it has not been easy to confirm that by using these diagnostic thresholds, the therapeutic procedures yield consistent benefits.2,3 As a matter of fact, to this date, it is recommended to use the same criteria as with primary MR (effective regurgitant orifice area ≥ 0.4 cm2 and regurgitant volume ≥ 60 mL).
Another issue under discussion is whether the best therapeutic strategy is valve repair or replacement. Most clinical trials have studied the easiest repair strategy, that is, restrictive annuloplasty. It consists of annular remodeling with a rigid or semirigid annulus that is 1 or 2 sizes smaller than the patient’s valve (usually determined by the intertrigonal distance or the anterior leaflet surface area). Despite the criticism received for the methodology used in the repair group and the results obtained after the procedure, several clinical trials conducted in the United States have shown no clear benefits of mitral valve repair over mitral valve replacement. However, a lower rate of MR has been reported in the group treated with valves.4,5 Several authors suggest that this repair method is not the best one, especially if the etiology is ischemic and considering that myocardial damage and remodeling—the true culprit of valve disease—is often localized and highly variable.
My opinion is that this field has finally entered the adult age. It seems obvious that there is not an easy way to treat all patients. Also, that success depends on the right selection of patients and techniques including, in particular, the use of techniques for the subvalvular apparatus like repositioning or papillary muscle sling. Secondary MR is a ventricular disease; this is what we all say, but most surgeons and cardiologists still try to solve it by only acting on the valve alone.
Q.: Which are the most suitable techniques today to repair mitral valves with organ failure?
A.: The best way to treat primary MR is surgical valve repair when possible. Such is the case of almost all patients with myxoid degeneration treated in experienced centers. Also, it is the therapy of choice to treat other etiologies such as endocarditis and rheumatic disease. However, the repair rate is lower and depends on lesions associated with the valve and in the remaining structures.
The association between primary MR repair and the experience of the treating center is well known.6 However, this experience is hard to gain; up to 50% of the patients who are eligible for valve repair keep are actually treated with valve replacements.7 This opens the debate of whether patients should follow specific patterns of referral to centers experienced on mitral valve repair to guarantee optimal results, especially young patients and during the early stages of disease (asymptomatic, in sinus rhythm, and with a normal left ventricle) as the current clinical practice guidelines recommend.8,9
Q.: Are there good surgical options to treat mitral annular calcification?
A.: Annular calcification is relatively common in rheumatic disease and in advanced cases of myxoid degeneration and, in general, does not pose a significant problem. However, a minority of patients show very extensive calcification of the valvular annulus with deep infiltration and spread towards the ventricular myocardial tissue. These cases pose a problem not easy to solve. Incomplete annular decalcification leads to fewer chances of achieving successful repairs and a higher risk of suboptimal results regardless of the technique used: associated residual MR and stenosis in the case of mitral repair or paravalvular leaks and insufficient valvular size in valvular replacement.
The solution to this problem is performing extensive decalcification, which is a complex procedure with associated risks. It often involves the aggressive debridement of the posterior atrioventricular sulcus and further reconstruction with some type of reinforcement material (autologous or heterologous pericardium or synthetic tissues like Dacron). This type of reconstruction requires the proper selection of patients and a very precise technique since its main complication—the tear of the posterior sulcus—is associated with high morbidity and mortality rates.
An interesting option recently presented although with scarce information on the mid-term results is a combination of a minimally invasive approach to prepare the valve followed by implantation under direct vision of an expandable valve, which optimizes valve fixation and avoids left ventricular outflow tract obstruction.
Q.: What is your opinion on less invasive surgical techniques to treat MR?
A.: I think that today they are the method of choice to surgically treat mitral valves because the benefits are obvious. We recently published our own experience on the management of mitral prolapse with a successful repair rate (98%) and a perioperative mortality rate < 1% in Revista Española de Cardiología.10 Minimally invasive thoracoscopic surgery was our preferred approach (more than 70% of the cases over the last few years) and is associated with less need for mechanical ventilation, shorter ICU stays, less blood loss, and less need for valve replacement at the 5-year follow-up (100% vs 95%).
Back in November 2019 we started our own robotic surgery program, the only one in Spain, with the Da Vinci system (Intuitive Surgical, United States), which basically focuses on mitral repair. By the time we were writing these lines, we had already treated 50 patients with very satisfactory results. In our early experience we think that the procedure is even less aggressive than thoracoscopy and is associated with further reductions of postoperative stays (median, 4 days).
There is no doubt in my mind that these minimally invasive techniques will keep growing and refining, and more patients will end up benefiting from repair surgeries less aggressively and with faster recovery times. Over the next few years, new robotic surgical platforms will be born for clinical use. Also, there will be new options for transapical neochord implantation without extracorporeal circulation. These advances will widen our current therapeutic armamentarium and join percutaneous techniques as part of our repertoire.
Q.: Tricuspid regurgitation (TR) is a complex condition of often unsatisfactory management. What does surgery have to offer these days and to who?
A.: TR has gradually been gaining the attention it deserves. One of the most important changes over the last few years is the confirmation of how important the early, prophylactic treatment actually is even when there is no left-sided valve disease when the procedure is performed.8,9 This adds to the recognition of the need to treat severe primary TR in isolation in patients with symptoms of right-sided heart failure and in asymptomatic patients with progressive right ventricular deterioration.9
Same as it happens with secondary MR, the management of functional TR requires understanding right ventricular remodeling and other associated nonvalvular lesions. Secondary TR has been treated with surgery too often and in a superficial way without the same level of attention and detail paid to left-sided valve disease. Same as it happens with mitral valve repair, the management of secondary TR requires a high level of training and experience. The results of valve repair are excellent in the landmark centers, and sometimes the use of additional techniques is required on the leaflets (anterior leaflet repair with patch augmentation), the subvalvular apparatus (papillary muscle repositioning, chordal shortening or transposition or neochordal implantation), the right ventricle (free-wall and annular plication), and the right atrium. These less traditional techniques allow us to bring the benefits of repair to cases of very advanced functional TR, primary etiologies and, in the case of secondary TR, to repair the damage caused by device wiring or thoracic traumas. A good example of these more complex and advanced procedures is the Da Silva’s cone repair technique in adult patients with Ebstein’s anomaly.11
Isolated tricuspid valve or concomitant to mitral surgery can also be treated through minimally invasive and robotic thoracoscopic surgery in experienced centers in most of the patients. The concomitant ablation of atrial fibrillation can follow too.
Q.: What does the future of interventional cardiology have in store with respect to heart surgery? Where should we look into from one specialty and the other?
A.: I personally see a bright future ahead for the patients (which is the most important thing of all), cardiovascular surgeons, and interventional cardiologists. The magnitude of these improvements and how fast they will spread out will depend on our capacity to acquire the necessary knowledge and skills to coordinate ourselves and collaborate with one another.
My opinion is that surgery needs to move towards perfecting training regarding valvular repair and minimally invasive techniques so that more patients can benefit from the better options available. The current low rates of valve repair in the management of mitral valve disease simply cannot stand. Together with cardiology we need to reflect on the current patterns of patient referral and look for formulas so patients can be operated on (whether surgically or percutaneously) in experienced centers. Also, patients need to gain access to all therapeutic options, and all the techniques available should be performed with optimal results based on scientific evidence, auditing, and the public disclosure of results.
FUNDING
None whatsoever.
CONFLICTS OF INTEREST
D. Pereda is a proctor for minimally invasive surgery for Edwards Lifesciences.
REFERENCES
1. Grigioni F, Enriquez-Sarano M, Zehr KJ, Bailey KR, Tajik AJ. Ischemic mitral regurgitation:long-term outcome and prognostic implications with quantitative Doppler assessment. Circulation. 2001;103:1759-1764.
2. Michler RE, Smith PK, Parides MK, et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2016;374:1932-1941.
3. Smith PK, Puskas JD, Ascheim DD, et al. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014;371:2178-2188.
4. Acker MA, Parides MK, Perrault LP, et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370:23-32.
5. Goldstein D, Moskowitz AJ, Gelijns AC, et al. Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. N Engl J Med. 2016;374:344-353.
6. Anyanwu AC, Bridgewater B, Adams DH. The lottery of mitral valve repair surgery. Heart. 2010;96:1964-1967.
7. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe:The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24:1231-1243.
8. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
9. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease:A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143:e72-e227.
10. Ascaso M, Sandoval E, Quintana E, Vidal B, CastellàM, Pereda D. Early and mid-term outcomes of mitral repair due to leaflet prolapse in a national referral center. Rev Esp Cardiol. 2021;74:462-4.
11. Fernández-Cisneros A, Ascaso M, Sandoval E, Pereda D. Cone repair for Ebstein's anomaly and atrial fibrillation ablation in an adult patient. Multimed Man Cardiothorac Surg. 2020. http://dx.doi.org/10.1510/mmcts.2020.064.
QUESTION: What is the current status of percutaneous coronary interventions to treat functional mitral regurgitation (MR)?
ANSWER: To this date, transcatheter mitral valve repair therapies are backed by the highest scientific evidence. This has been confirmed by the new clinical practice guidelines1 on the management of patients with valve disease published by the American Heart Association (AHA) where transcatheter repair (class IIa-Level of Evidence BR) is recommended for patients with functional MR and severe ventricular dysfunction. However, surgery is spared for cases that require concomitant coronary revascularization. We should not forget that transcatheter repair is the only technique on which there are randomized clinical trials available.2,3 That is why it is indicated as the first-line therapy by the clinical practice guidelines. We should put the old sayings «regarding a case» or «in my hands, results are better» to sleep. Multicenter randomized clinical trials assess the reproducibility of the technique, and that is the key to generalize this or that therapy. In my opinion, the clinical cardiologist should place transcatheter mitral valve repair in the same level as cardiac resynchronization therapy. And, same as it happens with resynchronization, the right selection of patients is of paramount importance. When should repair be considered? In patients on optimal medical therapy who still remain symptomatic with severe functional MR, ventricular dysfunction, left ventricular end-diastolic diameter ≤ 70 mm, and with a suitable valvular anatomy as seen on the transesophageal echocardiography.
Q.: In your opinion, which would be the potential niche to combine techniques that target the leaflets or the annulus in this context?
A.: Winston Churchill used to say: « However beautiful the strategy, you should occasionally look at the results». Combined therapy is a very appealing idea, yet the experienced reported on this procedure is very limited with very few cases published to this date. It has probably encountered 2 main limitations so far: edge-to-edge mitral valve repair can alter the anteroposterior diameter of the mitral annulus and has a 5-year durability time limit compared to surgery; on the other hand, the combined procedure significantly increases risk, complexity, and the cost of the procedure.
With this mind and taking into consideration that in the future low-risk patients with primary MR will be treated, it is likely that we’ll be seeing more reports on combined cases always with the objective of increasing the repair durability.
Q.: What does interventional cardiology have to offer to patients with organic MR who are not eligible for surgery? And what about the mitral annulus?
A.: The main advantage for patients with many comorbidities is that with transcatheter repair recovery is almost immediate (to this date, the average hospital stay is 48 hours) and the rate of complications is very low; the worst thing that can happen is unsuccessful repairs. That is why the main limitation is the impossibility of valvular replacement conversion with suboptimal results (actually something cardiac surgery allows).
Mitral annular calcification does not exclude transcatheter repair, but it can make it difficult due to the presence of less flexible leaflets, thus predisposing to a higher risk of leaflet tear and a greater final transmitral gradient. However, the wide array of devices available allows us to take on situations that we would have discarded in the past. In any case, this seems like the most interesting niche for transcatheter mitral valve repair.
Q.: What degree of clinical development have transcatheter mitral valves reached so far? In your opinion, which should be their indication with respect to repair techniques?
A.: The first series with over 100 patients have already been published with positive results.4 The main limitation here is the excessive selection of patients to guarantee positive results and avoid complications like left ventricular outflow tract obstruction. Over 60% of the patients assessed are eventually considered not eligible to undergo the procedure. Regarding the indication, for the time being, it should be spared for patients in whom the repair is not feasible or may be difficult. We still need data on valvular dysfunction and thrombosis at the follow-up.
Q.: Tricuspid regurgitation (TR) is a complex condition of often unsatisfactory management. What techniques are already available for the interventional cardiologist?
A.: That is true. Unfortunately, the mortality rate of isolated surgery on the tricuspid valve is high; actually, even higher regarding its repair (mortality rate > 10%). On the other hand, medical therapy is often limited by renal function. Also, if we consider that most TRs are functional, it seems like a perfect disease to use transcatheter techniques. That is why several devices we use nowadays to treat the mitral valve are also valid to treat tricuspid regurgitation.
For repair purposes, in the MitraClip device (Abbott Vascular, United States) the delivery sheath has been changed to approach the valve easier. The Triluminate study5 used this version of the device (Triclip), and confirmed that TR was reduced by, at least, 1 grade in 86% of the patients with a 4% rate of adverse events at the 6-month follow-up. This possibility is also being explored with the Pascal device6 (Edwards Lifesciences, United States), primarily with its ACE version, and the early results are similar to those published on the Triclip. The Cardioband7 (Edwards Lifescience, United States) is also available for this use and the early experience with 30 patients reduced TR to less than moderate in 73% of the patients at the 6-month follow-up
On the other hand, the field of tricuspid valve replacement is clearly heading towards the use of the femoral access almost exclusively (currently, in the mitral valve, the most consolidated valve is the Tendyne [Abbott, United States] that is implanted via transapical access). Many of the valves intended for the mitral valve are also being used in the tricuspid one where right ventricular outflow tract obstruction does not seem be a problem.
Finally, we also have heterotopic valves available that are implanted outside the thoracic cavity. The main advantage of these devices is a relatively easy implantation, and the fact that they can be used when the etiology of TR is interference with wires coming from other devices such as pacemakers, automatic implantable cardioverter-defibrillators, etc.
Q.: Which is the optimal clinical indication and anatomical context to use these techniques?
A.: The main clinical indication is patients with severe TR with signs or symptoms of right congestion that are persistent despite medical therapy and without signs of severe pulmonary arterial hypertension. In our case, the typical subject is a patient operated on the mitral valve (probably due to atrial fibrillation) who has been dilating the tricuspid annulus for years and now has severe TR that he did not have when he underwent surgery.
With respect to the anatomical context, maybe the main limiting factor regarding repairs is the echocardiographic window. It is important to know whether we will be able to achieve good projections to guarantee a proper device implantation. There are times that multimodal images including transthoracic, transesophageal or intracardiac echocardiography are required. The main limitation of edge-to-edge repair devices is the size of coaptation defect (in the Triluminate, the cut-off value was 2 cm, but the truth is that in defects > 1 cm it is already assumed that we’ll be needing more than 1 device), and in the case of the Cardioband the size of the annulus should be < 52 mm. Regarding valves, screening is performed through computed tomography scan and the limiting factor here is often the annular size. Heterotopic valves usually have very few limiting criteria.
Q.: What does the future of interventional cardiology have in store with respect to heart surgery? Where should we look into from one specialty and the other?
A.: From the medical point of view, we should probably not pay too much attention to which is the possible survival rate of this or that specialty, but where is the therapy heading to. Today’s medicine favors prevention over intervention, and the least invasive procedures over the most aggressive ones. For example, let’s look at the evolution surrounding the management of rheumatic mitral stenosis. We went from open commissurotomy as the early therapy to percutaneous valvuloplasty when it became available. However, thanks to early antithrombotic treatment there are fewer cases of mitral stenosis. This is the same path we should expect to follow with the remaining valve diseases we treat today.
We should focus on obtaining the most effective treatments causing the least possible damage to the patients. Therefore, it is our responsibility to work in order to a) use the least invasive access routes to boost the patients’ early recovery; b) minimize the impact of the learning curve of this or that therapy through early focus and the proper dissemination; c) consistently assess the results of a new therapy while being patient at the same time (and not trying to know if it is effective with the first 10 cases at the 1-month follow-up); d) be actively involved in improving the procedures (whether through patient selection, device improvement or further medical management); and finally as Hippocrates used to say «foolish the doctor who despises the knowledge acquired by the ancients», in other words, let us benefit from the cumulative experience acquired over time to avoid making the same mistakes over again.
Once a therapy has become consolidated the proper training criteria should be established to be able to perform it, which leads us directly to accreditation. The proper criteria should be established and then incorporated to the proper training, and the corresponding legal validity achieved for accreditation purposes. This can be extrapolated to all the super-specialties within the different fields of medicine. Training is well regulated from college throughout the Internal Medicine Residency (MIR) program. However, once the specialty training is over, it is necessary to regulate further training.
Maybe we should work on how to approach cardiovascular disease from an overall perspective. We should have teams working on prevention, others on diagnosis, and other teams on therapeutics. Interventional cardiology and surgery should be included in the latter group.
FUNDING
None whatsoever.
CONFLICTS OF INTEREST
D. Arzamendi is a proctor for Mitraclip and Triclip (Abbott), and Pascal (Edwards Lifescience).
REFERENCES
1. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease:A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;14:e35-e71.
2. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018;379:2307-2318.
3. Obadia J-F, Messika-Zeitoun D, Leurent G, et al. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018;379:2297-2306.
4. Badhwar V, Sorajja P, Duncan A, et al. Mitral regurgitation severity predicts one-year therapeutic benefit of Tendyne transcatheter mitral valve implantation. EuroIntervention. 2019;15:e1065-e1071.
5. Lurz P, Stephan von Bardeleben R, Weber M, et al. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021;77:229-239.
6. Lim DS, Kar S, Spargias K, et al. Transcatheter Valve Repair for Patients With Mitral Regurgitation:30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019;12:1369-1378.
7. Nickenig G, Weber M, Schüler R, et al. Tricuspid valve repair with the Cardioband system:two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021;16:e1264-e1271.
QUESTION: Briefly, what is the evidence behind the percutaneous left atrial appendage closure (LAAC) regarding oral anticoagulation (OA)? Is there any evidence on direct-acting oral anticoagulants (DAOAs)?
ANSWER: The LAAC has been compared to OA regarding the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF) in 3 randomized clinical trials: the PROTECT AF, the PREVAIL, and the PRAGUE-17. The first 2 ones randomized 1114 patients with NVAF and CHADS2 ≥ 1 on a 2:1 ratio to receive the Watchman device (Boston Scientific, United States) or warfarin. In an intention-to-treat meta-analysis of aggregate individual data from the 2 studies with 5-year follow-ups no differences were seen between both strategies in the primary composite endpoint of stroke, systemic embolism, and cardiovascular or unexplained death (hazard ratio [HR], 0.82; 95% confidence interval [95%CI], 0.58-1.17; P = .27).1 In the secondary endpoint analysis a higher—though not statistically significant—rate of ischemic stroke or systemic embolism was reported in the device group (HR, 1.71; 95%CI, 0.94-3.11; P = .08). On the contrary, the LAAC was associated with a lower rate of hemorrhagic (HR, 0.20; 95%CI. 0.07-0.56; P = .002) or incapacitating stroke (HR, 0.45; 95%CI, 0.21-0.94; P = .034), major hemorrhage unrelated to the procedure (HR = 0.48; 95%CI 0.32-0.71; P < 0.001), cardiovascular or unexplained death (HR, 0.59; 95%CI, 0.37-0.94; P = .027), and all-cause mortality (HR, 0.73; 95%CI, 0.54-0.98; P = .035).
The results of the PRAGUE17 clinical trial have been recently published. This study randomized 402 patients on a 1:1 ratio with NVAF and an indication for OA to LAAC with the Amplatzer Amulet (Abbott Vascular, United States) (61.3%) or the Watchman device (38.7%) or to a DAOA, mainly apixaban (95.5%).2 This trial only included patients considered of high risk with some of the following criteria: history of bleeding that required intervention or hospitalization, past medical history of embolism despite treatment with OA or CHA2DS2-VASc scores ≥ 3 with HAS-BLED ≥ 2. During the mean follow-up of 20.8 months ± 10.8 months no differences were seen in the composite primary endpoint (stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or clinically relevant bleeding or procedural or device-related complications) reaching criteria of non-inferiority (HR, 0.84; 95%CI, 0.53-1.31; P = .44; P for non-inferiority = .004). No differences between both groups were seen either in any of the events included in the composite primary endpoint separately.
Currently, there are 4 ongoing different randomized clinical trials that will be assessing the benefits of the LAAC with the Watchman FLX device (CHAMPION-AF [NCT04394546]), the Amplatzer Amulet device (CATALYST [NCT04226547]) or with either one of the 2 (OCCLUSION-AF [NCT03642509], CLOSURE-AF [NCT03463317]) vs DAOA therapy in patients with NVAF.
Q.: Which are the current indications for the LAAC? Should the clinical guidelines most recently published be changed somehow?
A.: The European guidelines on the management of AF published in 2020 suggest that the LAAC could be considered in patients with NVAF and a contraindication to OA (IIb level of recommendation, C level of evidence).3 Regarding this indication, I think a few considerations should be made. In the first place, the evidence available on the LAAC is limited basically because of the non-inferiority design of the clinical trials available with a limited number of patients. Also, due to the great heterogeneity of the antithrombotic therapy indicated post-LAAC, that could be conditioning the applicability of the results obtained. Secondly, the guidelines were written before the results of the PRAGUE-17 trial came out, that are consistent with the efficacy and safety profile of the procedure, also vs DAOAs (although in a limited 2-year follow-up) that is currently the treatment of choice to prevent thromboembolic events in patients with AF with, at least, moderate risk. Thirdly, since it is a «prophylactic» therapy, procedural success should be high, and the rate of related complications should be low. In this sense, in the largest registry published to this date of over 38 000 patients, the rate of procedural success was 98.3% and the rate of major complications, 2.16%.4 Finally, the lack of compliance to medical therapy and under or overdosing are common problems in our routine clinical practice, which has a significant impact on the efficacy of OA, which is probably reported in the randomized clinical trials as well.
Q.: Which is the common practice at your center?
A.: The patient’s profile eligible for this procedure is that of an elderly patient with an indication for OA due to NVAF with a previous episode of intracranial or gastrointestinal bleeding. Other less common cases are patients with chronic anemia or high bleeding risk with an indication for OA or dual or triple antithrombotic therapy. Finally, more and more patients with stroke despite being on OA are being reported. We perform a transesophageal echocardiogram (TEE) prior to the procedure in all the cases. We often perform implantation with mild sedation and TEE guidance with microprobe. Antithrombotic therapy upon discharge is based on every particular patient and followed-up at the specific structural heart disease consultation within the first year including TEE sometime within the first 3 months after hospital discharge.
Q.: How valuable are imaging modalities in the selection of patients and procedural guidance?
A.: The preprocedural study of left atrial appendage aims at determining the anatomical feasibility for implantation purposes, providing the right dimensions for a proper sizing of the device, and excluding the existence of thrombi. To this end, a 3D imaging modality should be used, usually a TEE or a computed tomography scan. The selection of one or the other will depend on its accessibility, experience of every center, and certain characteristics of the patient like the presence of kidney disease. Regarding the computed tomography scan, a 2-stage acquisition protocol with sensitivity and specificity rates close to 100% for the detection of thrombi should be conducted.
In most cases, the LAAC is performed with TEE guidance. However, this imaging modality has complications: on the one hand, the prolonged use of the probe can cause non-negligible oropharyngeal lesions. On the other hand, general anesthesia is required in many patients with the corresponding complications and increased procedural duration and costs. In this sense, as we have been gaining experience on device implantation, new options have come up to minimize these limitations like the TEE microprobe and the intracardiac echocardiography. The microprobe provides slightly lower quality of image compared to conventional TEE but is better tolerated by the patient and requires no general anesthesia. The drawback is that no 3D images can be acquired, which means that a previous study capable of providing 3D images is necessary. Regarding intracardiac echocardiography, the latest machines available provide better quality of images, some even the possibility of 3D reconstructions (still not on the market). They do not require the presence of an imaging specialist at the cath lab or use of a transesophageal probe either. On the other hand, both the cost of the device and its disposable nature reduce its utility in the routine clinical practice. Several ongoing prospective registries will be shedding light on the safety, feasibility, and possible technical advantages.
Q.: Are there any significant differences among the different devices available?
A.: Despite the technical advances made in the procedure, there are still pending challenges or, at least, room for improvement: a) great anatomical variability in the left shape, orientation, and size of left atrial appendage; b) risk of perforation with pericardial effusion; c) device embolization; d) persistent residual leak after implantation; and e) rate of device related thrombosis. For all these reasons, there are many devices to perform LAAC available today or in the pipeline that try to improve some of these aspects. Generally speaking, 2 important types of design can be distinguished here: tamponade-like devices like the Watchman, and anchor-disc shaped devices like the Amplatzer Amulet. In principle, the latter can be more versatile in complex anatomies while the first one has a growing body of evidence. Regarding procedural results, the observational data obtained do not suggest differences in the implantation success rate or in the rate of serious complications, device thrombosis or significant residual leak reported between the 2 most widely used devices to this date. However, the results from comparative studies AMULET IDE [NCT02879448] and SWISS-APERO [NCT03399851]5 will bring us more data on this regard.
There are many other devices available with scarce evidence and limited used, but with technical advances and very promising designs: extreme sizes, antithrombotic expanded polytetrafluoroethylene covering, self-adaptable configuration to the left atrial appendage ostium, small anchor with large disc configuration, highly flexible or articulated devices…Given the great anatomical variability of the left atrial appendage, maybe some devices will be complementary in the future. Therefore, if the volume of cases allows it, it can make sense to use more than just 1 type of device in every patient, the one more suitable to his anatomy.
Q.: Please tell us about any relevant ongoing clinical trials. In your professional opinion, what type of study should be conducted?
A.: There is no doubt that the most significant randomized clinical trials that are being conducted today are those comparing the LAAC to DAOAs. These trials will eventually determine the actual benefit of this procedure. Another very important aspect to elucidate is the optimal antithrombotic therapy to prevent device thrombosis. In this sense, the following randomized clinical trials should be highlighted: a) the SAFE-LAAC trial [NCT03445949] will assess the 6-month efficacy profile of dual antiplatelet therapy vs a 1-month course of dual antiplatelet therapy plus 5 months of single antiplatelet therapy; b) the ANDES trial [NCT03568890] will analyze the DAOA strategy vs an 8-week course of dual antiplatelet therapy; c) the FADE-DRT trial [NCT04502017] will be comparing the efficacy profile of 3 strategies consisting of a 6-week course of OA followed by a 6-month course of dual antiplatelet therapy, half-dose DAOA plus genotype-guided dual targeted therapy (acetylsalicylic acid + clopidogrel or half-dose DAOA depending on clopidogrel resistance or not); and d) the ASPIRIN-LAAO trial [NCT03821883] that will be analyzing the benefit of keeping single antiplatelet therapy starting 6 months after the procedure.
Another particularly interesting randomized clinical trial is the OPTION [NCT03795298] that will be randomizing 1600 patients treated with ablation due to AF to receive the Watchman FLX device or OA. Finally, from a theoretical point of view, evidence is still scarce in some potentially LAAC-eligible patients as it is in patients with recurring thromboembolic events despite OA or with NVAF and chronic kidney disease on dialysis. Both groups are characterized by a very high thrombotic risk. There is lack of consensus regarding the most adequate antithrombotic strategy that is empirically administered in most of the cases. Also, patients on dialysis have a high hemorrhagic risk and, unlike the general population, OA does not seem to benefit them. Some observational studies suggest that the LAAC can be safe and effective in these subgroups of patients. However, to this date, no randomized clinical trial has studied this therapy compared to others.
FUNDING
The author received no financial support for this work.
CONFLICTS OF INTEREST
None declared.
REFERENCES
1. Reddy VY, Doshi SK, Kar S, et al. 5-Year Outcomes After Left Atrial Appendage Closure:From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017;70:2964-2975.
2. Osmancik P, Herman D, Neuzil P, et al. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020;75:3122-3135.
3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020:ehaa612.
4. Freeman JV, Varosy P, Price MJ, et al. The NCDR Left Atrial Appendage Occlusion Registry. J Am Coll Cardiol. 2020;75:1503-1518.
5. Basu Ray I, Khanra D, Shah S, et al. Meta-Analysis Comparing WatchmanTM and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation. Front Cardiovasc Med. 2020;7:89.
QUESTION: Briefly, what is the evidence behind the percutaneous left atrial appendage closure (LAAC) regarding oral anticoagulation (OA)? Is there any evidence on direct-acting oral anticoagulants (DAOAs)?
ANSWER: The main clinical evidence published on this regard comes from 3 randomized clinical trials (2 vs anti-vitamin K and 1 vs DAOAs), registries, and case series. The PROTECT AF clinical trial1 included 707 patients with atrial fibrillation (AF) and CHADS2 scores ≥ 1 who were randomized on a 2:1 ratio to receive the Watchman device (Boston Scientific, United States) or warfarin. The composite endpoint (stroke, cardiovascular death, and systemic embolism) was less prevalent in patients with the Watchman device (relative risk [RR], 0.62; 95% confidence interval [95%CI], 0.35-1.25); however, adverse events were more common in the device group (RR, 1.69; 95%CI, 1.01-3.19) mainly due to periprocedural complications. These increased adverse events triggered a second clinical trial, the PREVAIL,2 that included 407 patients with CHADS ≥ 2 randomized on a 2:1 ratio to receive the Watchman device or warfarin. The primary efficacy endpoint at the 18-month follow-up (stroke, systemic embolism or cardiovascular or inexplicable death) occurred less often than expected in the warfarin group and the non-inferiority target was not achieved. However, the secondary efficacy endpoint (stroke or systemic embolism 7 days after implantation) was achieved; also, adverse events were less common compared to those of the PROTECT AF trial.
Data from the PROTECT AF1 and PREVAIL2 clinical trials were combined in a meta-analys3 that concluded that the Watchman device was not inferior to anti-vitamin K therapy for the composite endpoint of stroke, cardiovascular death, and systemic embolism. We should mention that patients with the Watchman device had lower chances of bleeding including hemorrhagic strokes. Nonetheless, there was a statistically insignificant higher rate of ischemic stroke and systemic embolism in the Watchman group.
The controversial aspect of these 2 clinical trials is that they only included patients with an indication for OA. However, in the routine clinical practice, the LAAC is used in patients contraindicated to OA.
The third and last clinical trial is the PRAGUE-174 that compared the LAAC to DAOAs. It included 402 patients with AF (CHA2DS2-VASc: 4.7 ± 1.5) and a past medical history of major bleeding or cardioembolic event while on DAOAs or with o con CHA2DS2-VASc ≥ 3 and HAS-BLED > 2. Apixaban was the most commonly used DAOA (95.5%). The median follow-up was 19.9 months. No statistically significant differences were found in the annual rates of the primary endpoint (stroke, transient ischemic attack, systemic embolism, cardiovascular death, clinically relevant or major bleeding or procedural complications) that were 10.99% with the LAAC and 13.42% with DAOAs (sub-hazard ratio, 0.84; 95%CI, 0.53-1.31 for non-inferiority). A total of 9 patients (4.5%) experienced major complications due to device implantation.
Regarding real-world registries, the NCDR LAAO5 is a large registry designed to assess the utility, safety, and effectiveness of LAAC percutaneous devices in the clinical practice. It includes 38 158 procedures performed in the United States. The mean score in the CHADS-VASC scale was 4.6 ± 1.5, and in the HAS-BLED scale, 3.0 ± 1.1. In-hospital major adverse events occurred in 2.16% of the patients; the most common complications were pericardial effusion that required intervention (1.39%), and major bleeding (1.25%), while strokes (0.17%) and death (0.19%) were rare.
Q.: Which are the current indications for the LAAC? Should the clinical guidelines most recently published be changed somehow?
A.: The most common indications in the routine clinical practice are high bleeding risk and contraindications to DAOAs (eg, dialysis), but as I said, the LAAC has not been studied in clinical trials with the proper statistical power in these subgroups
The recent guidelines published by the European Society of Cardiology (ESC)6 give the LAAC a class IIb recommendation and a B level of evidence for the prevention of strokes in patients with AF and contraindications to long-term anticoagulant therapy (eg, intracranial hemorrhage without reversible cause). The clinical guidelines published by the American Heart Association, American College of Cardiology, and the Heart Rhythm Society (AHA/ACC/HRS)7 also give it a class IIb recommendations as a therapeutic option for patients with an indication for oral anticoagulation, but with a high risk of bleeding, poor compliance or tolerance to anticoagulant therapy. In both guidelines, recommendations are limited. The consensus document published by the European Heart Rhythm Association (EHRA)8 regarding the LAAC makes an extensive review including the largest possible number of indications:
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1)Patients with contraindications to OA due to:
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a) High risk of potentially life-threatening or incapacitating hemorrhage or due to untreatable causes like intracranial/intraspinal bleeding (eg, diffuse amyloid angiopathy or untreatable vascular malformation) or severe gastrointestinal (eg, diffuse angiodysplasia) pulmonary or urogenital bleeding that cannot be corrected.
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b) Serious adverse events with anti-vitamin K therapy or contraindications to DAOAs.
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2) Patients who don’t follow their anticoagulant therapy properly. This indication is controversial, and we should always inform the patient that his main treatment is anticoagulation while trying to solve the problem associated with poor compliance.
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3)Some specific subgroups:
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a) Ineffective OA: stroke in a patient properly anticoagulated.
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b) After pulmonary vein ablation with left atrial appendage electrical isolation due to the high embolic risk involved after this procedure.
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c) Combination of pulmonary vein ablation and LAAC within the same procedure.
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d) «Primary» prevention: in patients with interatrial communication treated with percutaneous closure during the same procedure even before the patient develops AF.
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Q.: Which is the common practice at your center?
A.: The most common indications are patients with AF on hemodialysis who, we already know, are poor candidates to anti-vitamin K therapy and have contraindications to DAOAs. Also, patients with very high risk of bleeding without treatable cause, especially digestive or due to other causes (eg, Rendu-Osler-Weber disease) and always after trying to solve it with a DAOA.
Q.: How valuable are imaging modalities in the selection of patients and procedural guidance?
A.: The use of imaging modalities is essential if we wish to perform successful procedures. Before the intervention, the anatomy of the left atrial appendage should be studied to see if it is eligible for closure. Also, the right material should be chosen and the presence of thrombi in the left atrium and left atrial appendage should be discarded. In general, this preprocedural assessment is performed with a transesophageal echocardiography, yet the computed tomography scan has been gaining traction.
During the procedure, x-ray images and transesophageal echocardiography are the common imaging modalities to use. When available, intracardiac echocardiography can also be used.
Between 6 and 24 weeks after the intervention, a transesophageal echocardiography or a computed tomography scan should be performed to discard the presence of thrombi in the device (that can appear in up to 2% to 4% of the cases) and significant peridevice leaks (> 5 mm).8
Q.: Are there any significant differences among the different devices available?
A.: The need for antithrombotic therapy post-LAAC shows that there is room for improvement because this procedure maintains the bleeding risk for a longer period of time, and it is still unclear what the optimal protocol should be. The PROTECT AF and the PREVAIL clinical trials kept patients on warfarin and acetylsalicylic acid for 45 days followed by a 6-month course of dual antiplatelet therapy and then acetylsalicylic acid for life.
The guidelines published by the ESC6 recommend acetylsalicylic acid permanently, clopidogrel between 1 and 6 months after the procedure and, for the Watchman device, in cases of low-risk of bleeding, a 45-day course of OA after implantation.
The consensus document published by the EHRA8 includes general recommendations that are very similar to those from the guidelines published by the ESC.6 It also claims that in patients with very high-risk of bleeding the use of single antiplatelet therapy could be an option (acetylsalicylic acid or clopidogrel) for short periods of time. However, this should always be an informed decision and the patient should think about it thoroughly.
Q.: Please tell us about any relevant ongoing clinical trials. In your professional opinion, what type of study should be conducted?
A.: The main ongoing trials are the ASAP-TOO that is assessing the LAAC in 888 patients with AF considered ineligible for OA; the OPTION trial, that is studying 1600 patients with AF to see if the LAAC with the Watchman FLX device is a reasonable option to OA (including DAOAs) after pulmonary vein ablation; and the CATALYST and CHAMPION-AF clinical trials, that will be conducting a long-term comparison between the Amulet (Abbott Vascular, United States) and the Watchman FLX device with DAOAs in patients with an indication for anticoagulant therapy due to AF.
Future clinical trials should prioritize the study of new devices comparing them to DAOAs since they are currently the therapy of choice to prevent strokes in patients with AF, especially those with relative or absolute contraindications to anticoagulation therapy. The use of these devices in patients with ischemic stroke despite the proper anticoagulation therapy should be analyzed too by associating the LAAC with an DAOA and then comparing it to an isolated DAOA. Finally, it is essential to clarify antithrombotic therapy after implantation in order to minimize it, above all, in patients with high risk of bleeding, while still keeping its efficacy.
FUNDING
No funding was received for this work.
CONFLICTS OF INTEREST
None.
REFERENCES
1. Holmes DR, Reddy VY, Turi ZG, et al. PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation:a randomised non-inferiority trial. Lancet. 2009;374:534-542.
2. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the WATCHMAN Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy:the PREVAIL trial. J Am Coll Cardiol. 2014;64:1-12.
3. Reddy VY, Doshi SK, Kar S, et al.;PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure. From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017;70:2964-2975.
4. Osmancik P, Herman D, Neuzil P, et al. Left atrial appendage closure versus direct oral anticoagulants in high-risk patients with atrial fibrillation. J Am Coll Cardiol. 2020;75:3122-3135.
5. Freeman JV, Varosy P, Price MJ, et al. The NCDR Left Atrial Appendage Occlusion Registry. J Am Coll Cardiol. 2020;75:1503-1518.
6. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020;42:373-498.
7. January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. Circulation. 2019;140:e125-e151.
8. Glikson M, Wolff R, Hindricks G, et al. ESC Scientific Document Group, EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion –an update. Europace. 2020;22:184.
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Original articles
Review Articles
Original articles
Editorials
Ventricular pressure-volume loop and other heart function metrics can elucidate etiology of failure of TAVI and interventions
aDepartment of Mechanical Engineering, McMaster University, Hamilton, Ontario, Canada
bSchool of Biomedical Engineering, McMaster University, Hamilton, Ontario, Canada
Special articles
Role of computed tomography in transcatheter coronary and structural heart disease interventions
aServicio de Cardiología, Hospital Universitario Álvaro Cunqueiro, Instituto de Investigación Sanitaria Galicia Sur (IISGS), Vigo, Pontevedra, Spain
bServicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Instituto de Investigación Biomédica Sant Pau (IBB Sant Pau), Barcelona, Spain
cServicio de Cardiología, Complejo Asistencial Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
dCentro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
Debate
“Orbiting” around the management of stable angina
The interventional cardiologist’s perspective
aServicio de Cardiología, Complejo Asistencial Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
bCentro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
The clinician’s perspective
aInstituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain
bDepartamento de Medicina, Facultad de Medicina, Universidad Complutense, Madrid, Spain