Requirements and sustainability of primary PCI programs in Spain for the management of patients with STEMI. SEC, AEEC, and SEMES consensus document

INTRODUCTION

Although traditionally tricuspid valve disease has been considered a less serious condition compared to left-sided valvular heart disease, nearly 2 million patients in the United States suffer from moderate tricuspid regurgitation (TR). However, less than 10 000 patients are treated with surgery each year. Functional TR amounts to 90% of all cases of TR and is often due to tricuspid valve (TV) annular dilation (mainly in the anteroposterior diameter) and right ventricle (RV) dilation due to progressive left heart disease.1 TV has been considered “the forgotten valve” for years. This problem may be explained because it was believed that TR was well-tolerated and decreased after treatment of the left-sided valvular heart disease. However, patients with significant TR and heart failure often remain very symptomatic.2 The presence of moderate or severe TR is associated with a higher mortality rate regardless of other variables like the ejection fraction or pulmonary pressures. Mortality rate is > 25% per year.3^-5

Current data confirm that repairing the TV while performing left heart cavity surgery is safe. However, reinterventions due to persistent TR are associated with high morbidity and mortality rates.6 Recent studies show that isolated TV surgery is still the valve surgery that is most associated with higher surgical risk and mortality rates between 8.8% and 9.7%.7 Therefore, the percutaneous therapies for the management of TR are an alternative to conventional surgery for patients who, until recently, were eligible for conservative medical treatment only for being high surgical risk patients.

Depending on the repair anatomical target, devices can be divided into coaptation, valve annuloplasty, and replacement devices (whether in the orthotopic or heterotopic position). The most widely used technique is the edge-to-edge repair with the MitraClip device (Abbott Vascular, Santa Clara, United States) in the tricuspid position. The TriValve registry8 included over 650 procedures with the MitraClip device (66% of all percutaneous procedures performed on the TV). This article has 2 objectives: first, to propose a protocol for the echocardiographic assessment of TV in patients with TR to decide on the suitability and feasibility of performing tricuspid repair with this system and guiding the procedure on a step-by-step basis; and second, to review briefly other transcatheter percutaneous devices available today that have already become clinically relevant.

TRICUSPID VALVE IMAGING FOR INTERVENTIONAL PROCEDURES

All patients eligible for tricuspid percutaneous procedures should initially be treated with a transthoracic echocardiogram (TTE). If the valve can be repaired using the edge-to-edge technique, a more advanced assessment using the transesophageal echocardiogram (TEE) should be performed.

TVs that clearly interfere with pacemaker or implantable defibrillator leads, leaflet perforation, severe restriction or significant thickening should not be considered favorable on the TTE. The traditional views for TV assessment through TTE are the parasternal view on the TV modified long axis, the short axis, the modified apical 4-chamber view, and the subcostal view in the short axis.

TEE assessments are crucial to decide whether a procedure using this device is feasible or not. Anatomy should be adequate, yet images should have enough quality to guide the procedure; at times, anatomical variants or the presence of intracardiac prosthetic material can make the procedure unfeasible. The current TEE guidelines established by the American Society of Echocardiography include additional images for TV assessment purposes.9 Multiplane rotations and multiple views are important for correct leaflet identification including adjacent structures used as reference.10

TRICUSPID VALVE ASSESSMENT THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAM

The essential views for a detailed assessment of the TV regarding transcatheter procedures are:

1. Mid-esophageal 4-chamber view at 0º. The septal leaflet (adjacent to the aorta) and the anterior leaflet (adjacent to the RV free wall) can be seen when the transducer is in anteflexion position (figure 1). The posterior leaflet can be seen when it is in the retroflexion position.

Figure 1. A: mid-esophageal 4-chamber view showing the septal leaflet and the anterior leaflet. B: imaginary view in the 4-chamber view. C: deep trans­esophageal view. A, anterior; TEE, transesophageal echocardiogram; S, septal; CS, coronary sinus.

To optimize the images of the right heart structures, the transducer should be turned clockwise. The artifacts of the septum and aortic or mitral valves can block the view of the septal leaflet. Tricuspid annulus is measured in this view with open flap-like cusps at the end of the diastole.

2. Mid-esophageal view of the RV inflow and outflow tract (intercommissural tricuspid view) between 60° and 90°. It shows the imaginary line from the anteroseptal (A-S) commissure up to the posteroseptal (P-S) commissure. The anterior leaflet close to the aorta and the posterior leaflet on the lateral side can be seen (video 1 of the supplementary data). This is the reference view to obtain biplanar images for the assessment of the septal leaflet. By bringing the cursor close to the aorta (X-plane tool), the orthogonal view shows the A-S coaptation and the anterior and septal leaflets. By moving it away from the aorta towards the lateral position, the view shows the P-S coaptation and the posterior and septal leaflets. The same views should be acquired using the Doppler color technique (figure 2) to see whether the origin of the regurgitant jet is of anterolateral or P-S predominance.

Figure 2. Intercommissural mid-esophageal view. A: when placing the cursor next to the aorta, the orthogonal view shows the anteroseptal coaptation line. B: by moving the cursor towards the most lateral region, the orthogonal view is acquired showing the posteroseptal coaptation line. C and D: color biplanar imaging showing the origin of regurgitation jet. A, anterior; P, posterior; S, septal.

Also, these views are useful to measure the length of the leaflets, see coaptation defects, assess the movement of the leaflets, and see the presence of strings that can make the procedure difficult. The presence of serious restrictions in the movement of the septal leaflet limits the performance of the procedure with the current device.

3. Deep esophageal 4-chamber view at 0°. Since the right inferior border of the heart is close to the diaphragm, the deepest insertion of the TEE transducer reaches the distal esophagus, close to the gastroesophageal junction; it may be that this view will only show the right atrium and coronary sinus and no images of the left atrium (figure 1). This prevents left heart structure-related artifacts from happening like the acoustic shadowing that the mitral prosthetic material can cause on the septal leaflet. This is the optimal view to acquire 3D volumes.

4. Transgastric view. These views are acquired by advancing the transducer towards the stomach. Starting at the baseline transgastric short axis and by rotating the transducer between 20° and 40° and making small clockwise rotations with anteversion, the optimal view to see the 3 tricuspid leaflets is acquired (TV short axis). This is the only 2D (bidimensional) view to see the 3 cusps and commissures simultaneously with the posterior leaflet in the nearby field, the anterior leaflet in the distant field, and the septal one adjacent to the septum (figure 3 and video 2 of the supplementary data). Images need to be optimized to make sure we are positioned on the tip of the leaflets and parallel to the valvular view. To do this we can start with a 2-chamber transgastric view of the RV at around 90º-110°. By using the X-plane tool to place the cursor on the tip of the leaflets, the orthogonal view will be acquired (that will be the TV short axis). This view provides a great deal of information on the TV:

Figure 3. Transgastric view. A: transgastric short axis view of a tricuspid valve with 3 cusps. B: transgastric short axis view of an anatomical variant with 2 scallops in the anterior leaflet. A: anterior; A1, scallop 1 of the anterior leaflet; A2, scallop 1 of the anterior leaflet; Ao, aorta; P, posterior; S, septal.

 

 

The impact of 3D images is not as powerful when performing procedures on the TV compared to the mitral valve. Lang et al.12 suggest a standard image visualization to see a frontal view of the TV by placing the septal leaflet in the inferior position (at the 6:00 hour position). These recommendations were established at the end of the last decade when there were no transcatheter procedures and the surgical view was trying to be replicated. Rotating the image 90° with the aortic valve in the 11:00 hour position is currently the preferred option. This should improve our understanding of the anatomy of the TV by creating a common language between cardiac imaging specialists and interventional cardiologists.

The quantitative analysis of leaflets and annulus is performed through multiplanar reconstructions of 3D views.13 By placing orthogonal views on the tricuspid annulus at the leaflet insertion site, the TV short axis is acquired. After precise adjustment the annular diameters and area dimensions can be obtained (figure 1 of the supplementary data).

The new classification of TR with new degrees of massive and torrential severity can be crucial for the adequate classification of patients and to assess the procedural final results.14

KEY TRANSESOPHAGEAL ECHOCARDIOGRAM VIEWS FOR TRICUSPID VALVE CLIP REPAIR

There are 4 key TEE views to guide the TV clip implantation: 4-chamber, bicommissural, transgastic, and grasping views (capture of tricuspid leaflets inside the device). The former views have already been described; we will now focus on the latter.

Grasping view

This is the view that better shows the leaflets that should be treated and the clip with wide open arms. Finding the best grasping view for clip implantation in the tricuspid position is one of the most complex and important steps during the procedure. The first limitation to find it is that, unlike what happens in the mitral valve, there are no clear anatomical references to guarantee the perpendicularity of the clip with respect to the leaflets. That is why a correct alignment at transgastric level is critical. After finding this alignment, the transducer is removed to look for the grasping view at mid-esophageal level.

The most common strategy is to place a clip between the A and S leaflets and towards the TV most central region. To acquire the grasping view and see the A and S leaflets we should start at the intercommissural view and the multiplanar view, and the grasping view will often be found at around 160° (figure 4). Another option is to perform a TEE transducer sweep from 0° to 180° until finding a direct grasping view to actually see the leaflets and the clip with wide open arms. In any case, every patient should be handled individually since the TV has more anatomical variations than the mitral valve. Also, the angle between the intercommissural view and the coaptation line of the A and S leaflets can be < 90º and mislead the multiplanar assumptions. The real-time 3D TEE can be useful to guide the clip, but not so much with mitral procedures.

Figure 4. Search for the grasping view for the clip in the anteroseptal (A-S) position with respect to the center of the tricuspid valve. A: grasping view for A-S clip (discontinuous blue line). B: transesophageal echocardiogram (TEE) at 160° showing the clip with wide open arms and the anterior and septal leaflets resting on them.

STEP-BY-STEP PROCEDURE

In most cases, the MitraClip implantation in the tricuspid position is performed through femoral access under general anesthesia. It is monitored through fluoroscopy and TEE; the combination of the 2 is essential to achieve optimal results. This is the step-by-step procedure with the key data that should be assessed through imaging modality:

1. Percutaneous access through the right femoral vein using the Seldinger technique. A high-support guidewire is inserted through a 7-Fr introducer sheath towards the superior vena cava (SVC) and after access pre-dilation, the guide catheter (GC) is advanced towards the right atrium.

2. The GC is inserted similar to the way it is done in the mitral valve procedure and the handle is ± rotated approximately 180º in the direction (−). The GC is also rotated 180º counterclockwise to face the anterior region. Once in the right atrium, the dilator and the guidewire are removed, and the catheter is softly aspirated to avoid air embolism. The rotation is then released (−).

3. At this point, the procedure can be performed in 2 different ways. The first is using the handle (+) to increase the GC cuve and point directly at the TV. In this case, the clip catheter is normally inserted into the GC (blue line with blue line) while the GC guarantees the correct positioning of the device to perform leaflet grasping. In the second way, the most widely used, the clip catheter is inserted misaligned (90° counterclockwise or 180°; the authors of this article prefer the 180° misalignment). This technique facilitates the straddling (of the clip radiopaque markers on the GC) of the clip catheter on the GC (this should be done towards the SVC to avoid damaging surrounding structures). After reaching the straddling position, the A or M wheel (depending on the patient’s anatomy) will deflect the tip of the clip towards the target TV region. This technique allows a more versatile range of motion with the device to avoid orientation or distance issues between the tip of the GC and the TV target area. Over the next few steps we will be describing the GC-clip catheter misalignment technique. From the echocardiographic standpoint, these steps are monitored in the 90º-110° bicaval view with biplane trying to not damage any anatomical structures.

4. Once the straddling position has been reached, the A or M wheel (or a combination of the 2) is activated to deflect the clip towards the TV. The wheel selected will depend on the trajectory of the clip. The objective is to achieve the most perpendicular trajectory possible to the TV and avoid, as much as possible, the catheter from coming too close to the interatrial septum (called septal hugging). This circumstance will make the clip point at the TV lateral region. Fluoroscopy in the 45º left, anterior, oblique view is used to see the tip of the clip move towards the left of the screen, away from the septum, pointing towards the operator (figure 2 of the supplementary data). Echocardiographic monitoring will then move from the bicaval to the intercommissural view.

5. When the clip remains perpendicular on the TV, the GC clockwise rotation will move the clip towards the septal position. The GC counterclockwise rotation will move it towards the lateral region. The stabilizer advancement will bring the clip closer to the A-S commissure. After retraction, it will pass to the P-S commissure. This will allow complete range of motion and guarantee the correct location of the grasping (figure 5).

Figure 5. A: transesophageal echocardiogram in 3D zoom mode; periprocedural frontal view. The guide catheter can move inside the right atrium towards the aortic valve by advancing the entire system (red arrow) or towards the posterior leaflet by retracting it; the movement towards the septum (blue arrow) is possible through clockwise rotation of the guide catheter, and towards the right ventricle free wall through counterclockwise rotation. B: explanted heart, anatomic view. A, anterior; Ao, aorta; P, posterior; S, septal; CS, coronary sinus.

6. When the desired position has been achieved, the clip opens and perpendicularity is assessed. This should be done by using a 2D TEE in the transgastric short axis or by 3D zooming in the atrial view. The clip should be rotated smoothly so that it remains completely perpendicular to the desired grasping site (figure 6 and video 3 of the supplementary data).

Figure 6. With the clip on the tricuspid annulus the transgastric short axis (A) or 3D zoom (B) should be used to steer the clip. A, anterior; Ao, aorta; S, septal.

7. Afterwards, the clip closes at 60º and is advanced slowly towards the RV just underneath the leaflets to avoid interfering with RV strings or structures. It is advisable to perform this maneuver through fluoroscopy guidance in a 30º right, anterior, oblique view (RV long axis). This fluoroscopic view will confirm that the clip describes a straight trajectory and maintains its perpendicularity. Fine tuning the rotation of the clip can be made while advancing towards the RV, but it should not be done underneath the leaflets (to avoid string interference). Then, the clip slowly opens at 120º to later retract and guarantee the capture of the leaflets (figure 3 of the supplementary data and video 4 of the supplementary data).

8. Back in the RV, the perpendicularity of the clip with respect to the target coaptation line should be confirmed on the transgastric short axis view. Then, the grasping view should be looked for, that is, the view that better shows the target leaflets and the clip with wide open arms. It is essential to have good ultrasound imaging during grasping to guarantee the correct insertion of the leaflets and the perpendicularity of the arms of the clip. Repeated suboptimal captures of the leaflets should be avoided to not cause excessive damage (TV leaflets are thinner and more fragile compared to the mitral valve leaflets) (figure 7).

Figure 7. Examples of grasping view. A and D: patient 1, grasping from the intercommissural view at 75° and from the direct grasping view at 125°. B and E: patient 2, direct grasping view acquired at 0° and 160°. C and F: right, anterior, oblique projection to steer the movement of the clip. A, anterior; S, septal.

9. Once the leaflets have been captured, their insertion should be confirmed through multiple 2D TEE views. Also, the presence of tissue bridges should be verified (though 3D TEE views). Multiplane is very useful for assessment purposes. A TTE or an intracardiac echocardiography should be used in cases of uncertain leaflet insertion. The TV mean gradient should be measured to discard stenosis; in general, mean gradients > 3 mmHg are not recommended (figure 8).

Figure 8. A-D: grasping assessment in multiple views for leaflet insertion assessment and reduction of tricuspid regurgitation.

10. Standard release of the clip. Once it has been completely released, the degree and location of residual TR and need for new clip implantation should be assessed. The position of the new clips will depend on the location and amount of residual TR jets.

Since MitraClip XTR was introduced for the first time, most procedures have been performed using this device. It allows easier captures even when there are coaptation defects among the leaflets. The step-by-step procedure described here refers to the standard MitraClip device used today in mitral procedures. A modification of the Mitraclip device (in the GC) will soon be available to facilitate the steering and positioning of the clip (with excellent results in the 30-day assessment in the TRILUMINATE trial.15) This new version will replace the device mitral version. The steps will change too. Similarly, we will have a new iteration of the system within the next few months (TriClip).

There are several technical possibilities for clip implantation in the TV; the strategy can vary depending on the surface occupied by each leaflet and the location of the regurgitation jet. For the management of A-S coaptation defects, implanting the clip as close as possible to the center of the valve maximizes the reduction of TR. In patients with large coaptation defects, the most common strategy is to treat the A-S coaptation line using several clips and avoid the bicuspidization of the TV (video 5 of the supplementary data). An alternative to this can be to implant a first clip between the anterior and septal leaflets plus a second clip between the posterior and septal leaflets to create a triple-orifice TV (figure 4 of the supplementary data). In this sense, the triple-orifice technique can be superior to the A-S bicuspidization one because it achieves a direct reduction of coaptation defects and counteracts annular dilation by exerting traction forces in the annular anterior and posterior regions. However, the analysis of both strategies did not find any differences between the 2 regarding TR or clinical improvement.16

The selection of patients for tricuspid valve repair should include a combination of clinical, hemodynamic, and anatomical characteristics. Table 1 shows the criteria that define the optimal candidates who are eligible for TR repair using the MitraClip device.17 It should be emphasized that all patients should have symptomatic TR despite receiving optimal medical treatment, high surgical risk, and severe TR.

Table 1. Criteria to identify the ideal candidates for tricuspid repair with the MitraClip device

Optimal	Possible	Exceptional
Secondary TR with normal leaflets	Secondary TR with normal appearance of the leaflets or primary TR with valve prolapse	Significant leaflet thickening (rheumatic) or severe valve shortening or destruction or prolapse
Small coaptation defect (< 3-4 mm) and good leaflet mobility	Moderate coaptation defect (4-7.2 mm), reduced leaflet mobility	Large coaptation defect (> 7.2 mm) or severe leaflet restriction
Good TEE window	Enough echocardiographic window to see the leaflets	Insufficient echocardiographic window to see the leaflets
Without PM or ICD leads	Presence of PM or ICD leads without significant leaflet or clip interaction	PM or ICD lead-induced TR
Normal-moderately depressed RV function Normal size or moderately dilated RV	Moderately reduced RV function, moderate RV dilation	Severely reduced RV function or severe RV dilation
Normal pulmonary systolic pressure	< 60 mmHg-65 mmHg and pulmonary resistances < 4 WU	> 60 mmHg-65 mmHg or pulmonary resistances < 4 WU
ICD, implantable cardioverter-defibrillator; PM, pacemaker; RV, right ventricle; TEE, transesophageal echocardiogram; TR, tricuspid regurgitation; WU, Wood units. Reproduced with permission from Hausleiter et al.17.

The echocardiographic predictors of success during TR repair with the MitraClip device recently published are: the location of the jet in the A-S coaptation line or central region, and the coaptation defect between leaflets < 7.2 mm are the best predictors with the NTR device.17 Procedural success is also essential because it is a variable independently associated with better prognosis.8^,18

OTHER TRANSCATHETER DEVICES TO TREAT TRICUSPID REGURGITATION

Table 2 and table 3 show other transcatheter devices for the management of TR.

Table 2. Transcatheter tricuspid percutaneous repair devices

	Characteristics	Strengths	Challenges
Coaptation devices
MitraClip	Bicuspidation or triple-orifice of the TV First series published	Wide experience in the mitral valve Easy to use for the operators	Vascular access route Modified implant technique Valve configuration with 3 leaflets Not for annular dilation
Pascal	Similar to the TriClip device Bicuspidation or triple-orifice of the TV Advantage of the spacer for grasping	Probably easy to use for the operators Similar to the TriClip device	Modified implant technique Valve configuration with 3 leaflets Not for annular dilation
Annuloplasty devices
Trialign	Bicuspidation of the TV (posterior commissure) First series reported Pending study for CE marking	Surgical history High safety profile	Risk of damage to leaflets or right coronary artery Difficult technique TEE-guided Properties of the valve tissue
Cardioband	Flexible annuloplasty annulus First cases ever reported in humans	Surgical history	Little experience in the mitral valve Risk of damage to right coronary artery
TriCinch	Simple indirect annuloplasty Pending study for CE marking	Surgical history High safety profile Fully retrievable before stenting	Risk of damage to right coronary artery Dilation of the inferior vena cava
CE, European conformity; TEE, transesophageal echocardiogram; TV, tricuspid valve.

Table 3. Transcatheter tricuspid valve replacement percutaneous devices

Devices	Characteristics	Strengths	Challenges
GATE	Nitinol self-expandable orthotopic valve Leaflet capture and annular expansion	Abolition of TR Similar to surgical experience Catheter-based valve system, easy to use for the operators	Vascular access route Preoperative planning Voluminous device Defect in the conduction system
TricValve	Prevents the retrograde flow from TR into the cava veins Nitinol self-expandable valve with special design for the SVC and IVC	Easy to implant Symptomatic improvement	Vascular access route Preoperative planning No surgical history Anatomical restrictions Long-term effect of atrial ventricularization
Tricento	Prevents the retrograde flow from TR into the cava veins Self-expandable stent from the SVC towards the cava vein Biological bicuspid valve towards the right atrium preventing flow towards the cava veins	Easy to implant Symptomatic improvement	Vascular access route Preoperative planning No surgical history Anatomical restrictions Individual design Long-term effect of atrial ventricularization
IVC, inferior vena cava; SVC, superior vena cava; TR, tricuspid regurgitation.

 

Edge-to-edge repair devices

Pascal

This device is used for edge-to-edge repair by capturing the leaflets of the TV. This device uses clasps (metal blades to capture the leaflets) and paddles (arms that go into the leaflets) to gently grasp the leaflets against a spacer. The clasps move independently for better leaflet capture in the device, while the spacer increases the coaptation surface reducing leaflet stress. The complete system is 22-Fr and the device can be fully elongated favoring its interaction with subvalvular apparatus. The procedure is TEE-guided through transfemoral access and under general anesthesia. Under TEE and fluoroscopy guidance, the device is steered towards the TV and implanted similar to the MitraClip. In a recent communication, the early experience with the Pascal repair system for TR repair was reported. Out of 12 patients treated, 92% reduced their TR in, at least, 1 degree, and all of them improved their functional class at the 30-day follow-up.19 This early experience is encouraging, but more data are needed before using this device in a larger community of patients.

Annuloplasty devices

Trialign

The Trialign device (Mitralign Inc., Tewksbury, Massachusetts) is a transjugular suture-based annuloplasty system to reduce the tricuspid annular diameter through plicated leaflet tissue. During the procedure a pair of polyester sutures are released into the tricuspid annulus next to the anteroposterior and P-S commissures. It is then cinched using a polyester suture that obliterates the tricuspid posterior leaflet and fixates to the atrial side. The results of the SCOUT trial20 have already been published on the successful implantation of a pair of sutures in 14 out of 16 patients (87.5%). The mean reduction after the procedure was 37% in the tricuspid annulus and 59% in the regurgitant orifice area. A pair of sutures can be implanted in the anterior annulus to optimize the final outcome. There was no perioperative mortality and quality of life tests improved at the 1-month follow-up.

Cardioband

The Cardioband system (Edwards LifeSciences, CA, United States) is a percutaneous direct annuloplasty device for TV repair. It is implanted into the tricuspid annulus by a series of anchors that pass through the annulus and into the baseline RV myocardium following the natural shape of the annulus and sparing the septal region where it meets the atrioventricular node. Afterwards, it is cinched using TEE-guidance and the annular septal-lateral diameter is reduced.

The 6-month data of the TRI-REPAIR trial21 have been published. It included 30 patients and procedure technical success was 100%. There was a 9% reduction of the annular septal-lateral diameter, and a 50% reduction of the PISA (proximal isovelocity surface area) at the 6-month follow-up. Eighty-eight percent of the patients had New York Heart Association (NYHA) functional class I-II and improved results in the quality of life tests.

TriCinch

The TriCinch (4Tech Cardio, Galway, Ireland) is an annuloplasty device with a deflectable catheter and a coil system in its distal end that anchors to the tricuspid annulus. This anchoring generates traction in the entire annulus through a band connected to it. The anchor is implanted in the pericardial space to avoid detachment at follow-up. Fixation site is in the middle region of the anterior tricuspid annulus under fluoroscopy and echocardiographic guidance. Then the catheter is tightened to cinch the tricuspid annulus, reduce its A-S dimension, and improve leaflet coaptation. Lastly, a self-expandable nitinol stent is released inside the inferior vena cava (IVC) to secure the system and keep the tension applied. The implantation of the TriCinch device preserves the native anatomy and facilitates other future treatment options. The experience with animals confirms the safety and efficacy profile of this device.22

Valve replacement devices

The transcatheter replacement of the TV can be orthotopic or heterotopic. The first experiences with this technique used aortic valves for percutaneous implantation in the tricuspid position. The “valve-in-valve” or “valve-in-ring” percutaneous implantation of an aortic valve in the tricuspid position is more common. Acceptable short-term results with these procedures have been reported.23 However, the development of transcatheter tricuspid valve replacement systems in native TV is much more interesting.

GATE

The GATE bioprosthesis (NaviGATE Cardiac Structures, Lake Forest, CA, United States) is the only device available today experienced clinically in humans as compassionate use. Also, it is the only device that allows fully orthotopic transcatheter tricuspid valve replacements. It is a xenopericardial leaflet bioprosthesis inserted into a self-expandable nitinol scaffold. The nitinol stent is wider in the ventricular region, giving it a tronco-conical morphology that reduces the transvalvular gradient and minimizes the outflow tract obstruction (since very little material protrudes towards the ventricle). It can be implanted using the jugular approach or the right atrium through minithoracotomy; the femoral access is still under development. The necessary size for the jugular access is ≥ 14 mm because a 42-Fr introducer sheath is used. In both cases, at least 7 cm are necessary from the annular entry site to steer the device (which should be angulated 70º) so that it is perfectly coaxial to the annular plane.

The prosthesis is available in 5 different sizes (36 mm, 40 mm, 44 mm, 48 mm, and 52 mm). A slight oversizing (from 5% to 10%) with respect to the annular dimensions is advisable. To select the device size, it is required to measure the annulus using TEE and computed tomography scan. On the CAT scan, the distance between the annulus to the right coronary artery is a very important feature to avoid damage and have guidance during the procedure. The x-ray projection imaging of the implant is also derived from the CAT scan.

To this day, very few implants have been performed worldwide and always with compassionate use. Recently, the experience of the University of Columbia with 5 consecutive procedures has been published.24 Procedural success was 100% and the route of access was minithoracotomy in all cases. Only 1 patient died within the first 30 days after the procedure. Successful implantation was associated with improved RV remodeling, increased cardiac output, and a better NYHA functional class in most patients.

CAVI

The objective of CAVI (caval valve implantation) is to avoid return flow from TR to the cava veins. This means that the devices per se do not eliminate TR. They improve systemic venous congestion instead. The procedure is performed by implanting valves (in the early experience, non-dedicated balloon-expandable valves) into the origin of the IVC and SVC. The implant can be simple (IVC only) or double depending on the anatomical characteristics of the venous system drainage into the right atrium. There a special self-expandable CAVI device available too, the TricValve (P&F Products Features Vertriebs, Vienna, Austria), that consists of a nitinol stent specifically designed for low-pressure circulation. The largest sizes available are 38 mm and 43 mm for the SVC and IVC, respectively. This means that the optimal diameters of the anchoring area should be ≤ 35 mm (from 28 mm to 43 mm).

Both valves are released using the transfemoral access in a 27-Fr dedicated catheter. The IVC device is released with the portion covered inside the right atrium and the waist inside the diaphragm hiatus to allow the drainage of venous hepatic system. Although it has been the first transcatheter device ever used, it poses some problems because it does not correct TR. The long-term impact of the ventricularization of the right atrium, the persistent overload of the right atrium and RV, the persistent low cardiac output state, and the impact on the function of the RV prevent a more widespread use of this technique. The consequences of thrombotic complications remain unknown too.

Tricento

The Tricento device (NTV AG, Muri, Switzerland) is a sophisticated CAVI concept. It consists of a bicaval, anchored, covered stent with an element of the lateral bicuspid valve made out of a porcine pericardium that only requires a low closing pressure. The nitinol stent has radiopaque markers to allow precise positioning and orientation during implantation. Using the transfemoral approach, the device is released through a 24-Fr catheter. The Tricento is fully repositionable and retrievable until it is completely released. Because of the patients’ great anatomical variability, the stent should be individualized. Once again, the idea is to avoid return flow from TR towards the cava veins. However, all the main setbacks of the CAVI concept are applicable here.

CONCLUSION

There are several transcatheter therapies under development for the management of TR. This article standardized the basic echocardiographic views available for the selection of patients. Also, it stands as a guide for the TV implantation of MitraClip, the most widely used device today. Given the non-stop advance of these devices and cardiac imaging, both imaging and interventional protocols will be jointly developed.

CONFLICTS OF INTEREST

The authors declared no conflicts of interest whatsoever regarding this manuscript.

BIBLIOGRAFÍA

INTRODUCTION

Ischemic heart disease is still the leading cause of mortality worldwide and it amounts to up to 20% of the overall deaths in Europe.1 The ST-segment elevation acute myocardial infarction (STEMI) is one of the most relevant forms of presentation. Early reperfusion is the most effective way to reduce morbimortality in STEMI. It was soon confirmed that fibrinolysis could not reestablish the patency of the coronary artery found in up to 20%-45% of patients2 with a 5%-10% acute coronary re-occlusion after successful fibrinolysis and a rate of late occlusion close to 30%.3 Primary angioplasty or more precisely, primary percutaneous coronary intervention (pPCI) did obtain significantly higher success rates in reperfusion above 90%,4 which is associated with a 30% relative reduction in mortality rate at 30 days and a lower risk of reinfarction and stroke.5 For this reason, pPCI became the gold standard treatment for the management of STEMI. However, the benefit of pPCI over fibrinolysis is only evident when performed at adequate centers by experienced teams (infarction centers) and within the first 120 minutes after the first medical contact.6

The pPCI not only is more effective and safer compared to fibrinolysis but recent studies show that it is cost-effective from the socioeconomic point of view, regardless of the initial high cost of its logistical and technological implementation.7^,8 In a study conducted in the United States,9 reperfusion through pPCI was associated with lower hospital costs initially compensated with the higher personnel costs (on call 24/7); however, when used in large volumes of patients, the pPCI was much more cost-effective. This higher cost-effectiveness is the product of eliminating the cost of fibrinolysis, the lower incidence of ischemic and hemorrhagic complications, the lower need for coronary angiographies and ischemia detection imaging modalities, the shorter initial hospital stay due to readmissions, and patients’ early return to professional life.

In an attempt to offer the best reperfusion strategy to the highest number of patients and within the recommended timeframes, several scientific societies recommended the creation of STEMI care network systems in the community and regional settings to provide the fastest possible healthcare to these patients.6 However, the implementation of these reperfusion networks requires important organizational and logistical changes. And this is a complex situation in Spain since the allocation of resources from the different healthcare administrations of the 17 autonomous communities (AACC) is decentralized and, therefore, budgets are managed independently. The organization and implementation of the healthcare system is also decentralized in this system. This leads to the heterogeneous provision of services. The way pPCI networks work and the results obtained from these networks are highly influenced by several factors such as geography, the number of pPCI-capable centers, referral times, the availability of adequate resources, infrastructure, and the characteristics of healthcare systems per se.10 Similarly, the heterogeneity of the financial situation and the structures of the different healthcare systems have led to great inequalities in the ways these networks have been organized; differences noticeable not only among different countries, but also among different geographical areas within the same country.10^-13 All these aspects translate into challenges and threats when it comes to the optimal implementation of STEMI care systems in Spain and they should be studied and analyzed in search of proposals and solutions that meet their needs.

This document has been agreed by different scientific societies (table 1) with the following goals in mind:

Table 1. Scientific societies, working groups, and representatives that have participated and signed the consensus document

Representative	Society
Ángel Cequier	Spanish Society of Cardiology (SEC)
Armando Pérez de Prado	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Ana Belén Cid	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Javier Martín-Moreiras	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Oriol Rodríguez-Leor	Working Group on Hemodynamics and Interventional Cardiology of the SEC
José Ramón Rumoroso	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Ana Serrador	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Raúl Moreno	Working Group on Hemodynamics and Interventional Cardiology of the SEC
Sergio Raposeiras	Working Group on Ischemic Heart Disease and Acute Cardiac Care of the SEC
Albert Ariza	Working Group on Ischemic Heart Disease and Acute Cardiac Care of the SEC
Esteban López de Sá	Working Group on Ischemic Heart Disease and Acute Cardiac Care of the SEC
Andrés Íñiguez	SEC
José Luis López Sendón	SEC
Francisco Javier Delgado	Spanish Association of Nursing in Cardiology
Rocío Gil Pérez	Spanish Association of Nursing in Cardiology
José Julio Jiménez- Alegre	Spanish Society of Emergency Medicine
Manuel José Vázquez	Spanish Society of Emergency Medicine
José Manuel Flores	Spanish Society of Emergency Medicine
Héctor Bueno	SEC
Manuel Anguita	SEC

 

 

ORGANIZATION OF HEALTHCARE NETWORKS FOR THE MANAGEMENT OF REPERFUSION IN SPAIN

Initial experiences and progress made by healthcare networks

The first experiences with structured programs of reperfusion with pPCI for the management of patients with STEMI in Spain date back to 2000 to 2001 in the Community of Navarre and the Region of Murcia, respectively where all patients were referred to a single reference center.14 The first multicenter program started in Galicia back in 2005. A series of centralized pPCI programs were defined then where geographical location-based isochrones were categorized, the healthcare centers where patients should be referred to were identified, and the healthcare and transfer resources needed were described. From early on, it was evident that these networks determined an increase in the number of STEMI patients treated with the best reperfusion therapy available at the time.15

Back in the year 2008, the AACC of Murcia, Navarre, Galicia, and the Balearic Islands had already implemented network structures that, at that time, meant that 12.8% of the Spanish national territory was covered. That same year, the Stent for Life initiative was born, a European project implemented by the European Association of Percutaneous Cardiovascular Interventions, and designed by interventional cardiologists, health Administration officials, patients, and healthcare industry providers. The goal of this initiative was to stimulate and facilitate the implementation of healthcare networks that would allow any STEMI patient to have access, in the least amount of time possible, to reperfusion therapy through pPCI. Spain started collaborating in this program back in 2009 in an attempt to identify regions with implementation deficiencies and to promote the elimination of barriers responsible for delays in the healthcare process. The project was based on prior experiences in the development of new projects. Also, it was decided to create and maintain reliable activity registries with campaigns aimed at training the population and making health authorities more sensitive to this issue.16 Nowadays, this initiative is called Stent, Save a Life and it has been brought to other continents to promote the development of healthcare networks in developing counties.

In 2009, Catalonia established its own pPCI and 3 years later, in 2012 Asturias, Cantabria, and Castile-La Mancha followed. Then, it would be the turn for Madrid, Valencia, Aragon, La Rioja, and the Basque Country. All these AACC have active regional programs generically known as Infarction Code. These changes in the reperfusion strategies reduced significantly the rates of thrombolysis, while the percentage of patients treated with pPCI increased gradually with an increase of territory coverage and number of interventions performed accross the country10^,17 which is consistent with what was already happening in other European countries.18

Numerous experiences have been reported that exemplify the benefits of implementing STEMI care networks, both in the European19 and domestic settings.20 One study10 analyzed the connection between the implementation of reperfusion networks for the management of STEMI in AACC, the regional rate of pPCI and hospital mortality. Throughout the entire period studied, there was a higher rate of pPCIs in all AACC (54.5% in 2012 vs 21.6% in 2003) (figure 1). It was confirmed that crude mortality rate was higher in non-reperfused patients (17.3%) compared to patients who had undergone pPCIs (4.8%) or fibrinolysis (8.6%; P < .001), with a lower risk-adjusted standardized mortality ratio (of 10.2% in 2003 and 6.8% in 2012; P < .001). In sum, the implementation of reperfusion networks was associated with a 50% increase in the rate of pPCIs and a 14% reduction in mortality rate (figure 2).

Figure 1. Changes in reperfusion strategies for the management of ST-segment elevation acute myocardial infarction in the Spanish health public system between 2003 and 2012. The evolution of reperfusion strategies can be seen over the entire study period. The percentage of patients treated with primary percutaneous coronary interventions (pPCI) increased gradually and simultaneously with moderate drops in the rate of thrombolysis. (Reproduced with permission from Cequier et al.10)

Figure 2. Correlation between the rates of primary percutaneous coronary interventions (pPCI) and mortality in the management of patients with ST-segment elevation acute myocardial infarction in the Spanish health public system between 2003 and 2012. There was a significant correlation between the rates of pPCI and mortality over the entire study period. RSMR, risk-standardized mortality rate. (Reproduced with permission from Cequier et al.10)

Reperfusion networks in Spain: current situation

Situation of the pPCI networks

Over the last few months, we have been able to provide coverage to the entire Spanish territory through regional healthcare net- works for the management of STEMI patients. In some cases, these pPCI programs do not have fully structured regional networks and depend on local circuits limited to a certain number of hospitals. Taking all these aspects into consideration, the number of per population-pPCIs has changed dramatically in our country, with a reduced number of patients treated with pPCI in AACC that did not have complete and structured programs before17 (figure 3). Consequently, the lack of homogeneity in the creation and development of the different reperfusion programs in the different AACC has brought many differences to these programs, some of them created exclusively by healthcare providers themselves with almost no institutional support. Also, other programs have seen the involvement of the Administration with detailed analyses of subdivisions, logistics, and infrastructure, and the provision of all necessary resources. This has originated a significant heterogeneity in the structure and organization of the different programs and in the assessment of different quality indicators and results. The information available shows that establishing a systematic and organized pPCI program makes a very favorable impact on prognosis compared to having unstructured pPCI programs without a preestablished transfer logistics20 (figure 4). Since there is not such a thing as a national pPCI registry, we do not know what the real volume of activity is in these programs or under what quality standards they have been implemented. Recent initiatives started by the Spanish Society of Cardiology (SEC) aim at promoting healthcare and evaluating the results of STEMI care (SEC-CALIDAD).21

Figure 3. Primary percutaneous coronary interventions (pPCI) per million of inhabitants over the years 2016 and 2017 in all Spanish autonomous communities. Those communities without fully structured network programs (Andalusia, Canary Islands, and Extremadura back in 2016) show the lowest number of patients with ST-segment elevation acute myocardial infarction treated with pPCI (Reproduced with permission from Cid Álvarez et al.17)

Figure 4. Prognostic impact of patients from a primary percutaneous coronary intervention (pPCI) program in a subdivided region before (precoding) and after (coding) the implementation of pre-established intervention and transfer logistics measures with regional hospitals and emergency medical services. There is a significant improvement of survival rate over the first year after implementation. (Reproduced with permission from Gómez- Hospital et al.20)

Situation of healthcare providers conducting pPCIs

In an effort to obtain information on how the actual pPCI programs work in Spain, in May 2018 the Working Group on Hemodynamics and Interventional Cardiology of the SEC conducted a survey among all its members called Needs and requirements of primary angioplasty program: a professional survey (O. Rodríguez-Leor, personal information). The questionnaire collected information on the activity of the programs already running in all the centers and on the degree of satisfaction of the personnel involved. Out of the 390 interventional cardiologists surveyed, 172 (44%) filled in the questionnaire. The mean age of respondents was 45 ± 8 years old (interquartile range: 39-50 years) and they all had over 9 ± 6 years of experienced managing primary angioplasty programs. The centers performed an average 292 procedures per year (200-410). All AACC were represented in this survey.

A very important aspect was that 45% of the respondents were not getting any breaks after night code activations. In almost half of the cases of those who actually got a break, they did not have access to their resting hours the next day because these hours had to be adjusted to the actual logistics needs or volume of activity of their department (figure 5). Another remarkable aspect is that over 50% of the respondents said their intention was to stop doing night calls whenever they were eligible due to their age (figure 6A). On the other hand, a high percentage of respondents (85%) said that the management of patients had room for improvement within their actual programs (figure 6B).

Figure 5. Hourly schedules and types of rest after being activated to perform primary percutaneous coronary interventions during night shift. Only 25% take a break of at least 8 hours after performing this procedure. Forty-five percent immediately move on to their routine clinical practice the next day with no downtime. (Data gathered from a survey conducted among members of the Working Group on Hemodynamics and Interventional Cardiology of the Spanish Society of Cardiology.)

Figure 6. A: Willingness to remain available or leave the on-call primary percutaneous coronary intervention (pPCI) programs after no longer being mandatory due to age. Fifty-four percent of respondents will leave these programs. B: Answers to the question of whether respondents thought that there was room for improvement for the management of patients with ST-segment elevation acute myocardial infarctions within pPCI programs. Eighty-five percent said that there was room for improvement. (Data gathered from a survey conducted among members of the Working Group on Hemodynamics and Interventional Cardiology of the Spanish Society of Cardiology.) DK/DA, did not know/did not answer.

Back in 2012-2013, another survey was conducted among the nurses of 52 centers that showed that in 64% of the cases, those who had been on call did not have any time to rest, and only 7% had access to some sort of rest over the next 12 hours (V. Rodríguez, personal information). Eighty-four percent of respondents did not get any time in lieu.

The results from these surveys should make us think of the future threats and risks of the actual models of human resources in certain pPCI programs.

SPECIFICITIES OF pPCI PROGRAMS

The particular characteristics and specific requirements of pPCI programs can put them in a scenario of vulnerability that will gradually make it very difficult to keep their sustainability if these programs are not implemented under the right conditions from the point of view of structure, organization, human resources, and equipment.

One of the key aspects of pPCI is the immediacy of the healthcare provided. In STEMI patients there is a direct correlation between the time the artery has remained occluded and early and long-term morbimortality. The occluded artery should be opened as soon as possible, which is why the time elapsed since the patient is first assisted until the artery is opened is a critical factor to determine the effectiveness of the procedure and results.22^,23 Although time limit when it comes to selecting the optimal reperfusion strategy (pPCI vs fibrinolysis) is 120 minutes, the recommendations of the clinical practice guidelines established by the European Society of Cardiology have become more and more demanding. They indicate that the maximum amount of time that should elapse since the diagnosis of STEMI is established until angioplasty guidewire crossing should not exceed 60 minutes in patients admitted to pPCI-capable centers, and should not exceed 90 minutes in patients transferred from other centers.6 A pPCI program should guarantee achieving diagnoses immediately, conducting urgent transfers and interventional procedures in a short span of time. The implementation of a pPCI program requires close collaboration of all teams involved in the healthcare system (primary care, regional hospitals, emergency rooms, emergency systems and transfers, and infarction centers).

Compared to other urgent care settings, even high-risk settings, there is a series of aspects exclusive and specific to pPCI programs:

 

 

The following features define the landmarks for a healthcare network system to be successful in the management of STEMI patients:

 

 

REQUIREMENTS AND NEEDS FOR THE RIGHT DEVELOPMENT OF pPCI HEALTHCARE NETWORKS

Subdivisions. Geographical regions

Spain is the fourth largest country in Euope, yet its population density is lower than most Western European countries, with a very irregular territorial distribution. This circumstance, especially in healthcare network systems makes it difficult to provide similar health coverage in the entire territory. In order to solve this problem, it is important to subdivide healthcare into geographical regions where healthcare to patients can be provided effective and homogeneously. Although certain recommendations have already been established by the European Society of Cardiology on what the reference population should be per cath. lab, its implementation in the pPCI setting is much more complex. Initially, a subdivision based on time isochrones is required so access to pPCI is guaranteed from the different healthcare providers to the largest amount of patients possible with transfer times within the timeframes recommended by the clinical practice guidelines, but only towards adequately equippedinfarction centers capable of performing a minimal number of pPCIs each year.24 The geographical barriers among different AACC should not be an obstacle for transfer logistics, since patients with an indication for pPCI should be transferred to the closest infarction center. Prior administrative agreements signed by the AACC involved should be taken into consideration. Patients who live in remote areas or who due to logistics or climate issues cannot undergo pPCI within the timeframe recommended should be treated as soon as possible with fibrinolysis and then transferred to infarction centers so that the pharmaco-invasive strategy can be initiated.25,26

Logistics-related aspects. Communications systems

To achieve these goals, logistics requires a 100% committment from all healthcare providers involved, particlularly from the transfer systems. It is important to have agile communication systems from a centralized structure (emergency coordination centers) capable of promptly notifying the infarction centers on the arrival of a patient, the transfer estimate time, and the patient’s clinical state so that the receiving center can adapt its daily activity to the arrival of an unexpected urgent procedure.24 Some programs include patients’ clinical description and electrocardiogram results before activation, thereby reducing the amount of diagnostic mistakes. On rare occasions, when several patients need to be transferred to the same center at the same time, or when the receiving center is busy with uncancellable activities, patients should be transferred to other close-by infarction center capable of providing the healthcare required.

Medical emergency systems

Medical emergency systems (MES) with doctors aboard the ambulance are a reality in Spain; however, the decentralization and transfer of health competences to the different AACC has generated different healthcare models. In the pPCI programs, MESs should be easily accessed over the phone through emergency coordination centers capable of triaging the urgent care requested. This request for help can come from private households, the street, or primary hospital or care centers. Afterwards, MESs activate the units that provide initial care and, if required, the transfer of the patient to the infarction center. Emergency coordination centers should have STEMI categorized as a time-dependent condition that requires priority care to achieve better results.24 Within the pPCI program setting, emergency coordination centers should meet a series of prerequisites and have:

 

 

The care provided to STEMI patients should be initiated by the first medical team available with the aim to examine the patient and interpret the electrocardiogram in less than 10 minutes. If diagnosis is confirmed, the corresponding healthcare protocol should be activated, and the patient transferred to a pPCI-capable center. A complete transfer of information on the patient’s clinical situation among the healthcare unit, the emergency coordination center, and the destination hospital is crucial. This approach should also be used with patients initially assisted in non-pPCI capable centers.6^,24

The initial transfer of these patients should happen in MES mobile units with teams including physician, nurse and paramedics trained and accredited according the level of competence established. The receiving hospital should know what the estimated time of arrival should be able to organize the care to be provided (on business hours) or to activate the treating hemodynamics team (off business hours). The patient should be transferred directly to the cath. lab without stopping at the ER.6^,24

It is essential that the MES team writes down a complete medical report including the aforementioned timeframes, the initial assessment, the interpretation of electrocardiograms, the medication administered, the patient’s progression, and any other complications that may arise. These teams should conduct periodic quality assessments of the healthcare provided to detect possible ways to improve this process. A system for the periodic exchange of information between the MESs and the hospitals treating the patients transferred should be established to analyze the quality and observance of the plans of action previously agreed on. There should always be MES resources available based on the established population ratios.

Infrastructure and equipment

The pPCI-capable interventional cardiology units and the cardiology services and centers where these units are headquartered should meet structural, functional, and organizational requisites to guarantee safety, quality, and efficiency conditions to perform such procedures. The following quality standards and accreditation criteria for reference units on the performance of pPCIs procedures27 and the standards and criteria that regulate the entire STEMI process have been recently agreed upon and published by the SEC (SEC-EXCELENTE):21

 

 

 

 

Regarding CICUs, the care of patients after undergoing pPCI should be consistent with the structure and functioning of each hospital. It is advisable that the centers of pPCI receiving units have a cardiology unit-dependant CICU. The decision to hospitalize a patient should be based on the level of care required by each patient (table 2).

Table 2. Levels of care

Level	Description of the need for healthcare
0	Patients whose needs can be met through normal ward care in an acute hospital
1	Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice and support from the critical care team
2	Patients requiring closer observation or intervention including support for a single failing organ system or post-operative care and those ‘stepping down’ from higher levels of care
3	Patients requiring advanced respiratory support alone or monitoring and support for two or more organ systems. This level includes all complex patients requiring support for multi-organ failure

CICUs with level-2 and level-3 care should:

 

 

Units with level-1-care should have a nurse/patient ratio > 1:6, have the necessary equipment and material available, and meet the standards designed by the European clinical practice guidelines.6 The amount of beds recommended is nine beds for every 100 000 inhabitants within the scope of influence of the pPCI program, but it can be smaller if there is a referral program to send the patients back to their reference hospital. The amount of beds required for level-1-care is and conventional hospitalization (level-0-care) is reduced accordingly.

Human resources

The interventional cardiology units included in the pPCI network should have a 24/7, all year round service on call.6 The team on call should include:

 

 

After activation, the time of arrival of the hemodynamics team should not exceed 30 minutes. The necessary measures to work within this timeframe should be implemented.

Post-procedural transfers. Early discharge

The transfer of patients once the pPCI has been performed is not uniform and is influenced by several aspects. Depending on the infrastructures, the personnel available, the availability of beds, the initial location of the patient after the pPCI, his clinical stability, and the level of complexity of the receiving hospital, the strategies for the management of patients post-pPCI can vary significantly. There are centers that accept and hospitalize all patients after the pPCI; others, however, keep them under observation for 12-24 hours prior to transferring them, and there are centers that transfer all patients as long as they remain stable after the pPCI.

Taking into consideration the pPCI setting and its possible complications, it is advisable that patients remain under strict observation the 12-24 hours following the procedure, preferably at the infarction center. Depending on the degree of clinical stability and the characteristics of the receiving center, patients can be transferred to their reference hospitals or remain hospitalized under observation or complete the necessary additional treatments that may be required. The models established for the transfer of patients to other centers are determined by the patient’s clinical characteristic, the applicable regional protocols, and the resources available. Patients whose procedure has had optimal results, who have undergone an adequate clinical evaluation, have no signs or symptoms compatible with persistent ischemia, do not show any traces of arrhythmia, remain hemodynamically stable, do not require vasoactive or mechanical support, and without a new revascularization scheduled are eligible for early transfers. Although some MESs already implement them, the widespread use of risk stratification indices and scores to allocate the most adequate resource for the transfer of these patients, and the systematic assessment of these indices and scores is strongly advisable.

Several studies have shown that after a successful pPCI in low-risk patients who were completely revascularized, a significant percentage of patients can be discharged from hospital to their home two or three days after the procedure. Patients eligible for early discharge after STEMI can be identified using risk scores such as the PAMI-II criteria (Second Primary Angioplasty in Myocardial Infarction), the Zwolle risk score, etc.6

Additional prerequisites of pPCI programs

The units that are part of a pPCI network should meet a series of additional requisites:

 

 

VULNERABILITIES OF THE ACTUAL pPCI PROGRAMS

Some pPCI programs were initially developed with partial or incomplete prior analyses, limited official support, and poor resources. The progressive expansion of pPCI programs and their widespread use in most STEMI patients have allowed to identify a series of deficiencies and shortfalls that may make them vulnerable and eventually jeopardize their own sustainability.

Impact on daily activity and volume-based care

According to the 2017 registry run by the Working Group on Hemodynamics and Interventional Cardiology, pPCIs amount to almost 30% of all interventional procedures performed in the cath lab.17 Data from different studies35,37 show that between 55% and 70% of all pPCI procedures are performed during off business hours (nights and weekends); however, the remaining 30%-45% procedures on STEMI patients are performed during business hours. The arrival of this large and unexpected volume of urgent and non-scheduled patients to the cath lab disturbs the scheduled daily activity of the unit since the patients require the fastest possible care these cath lab can provide. Depending on the level of adequacy that each center can establish to anticipate this, the routine activity of these cath labs may change, and cases may be suspended (ie, in-patients, cath lab scheduled patients or patients from other centers) and the usual working hours extended to avoid cancellations. Thus, optimizing the STEMI treatment may deteriorate the care that should be provided to other patients with serious heart conditions.

Psychological, legal, and economic implications in healthcare providers

The lack of appropriate sizing of the personnel involved in pPCI programs may be the reason behind two important issues: the development of psychosocial issues and the emergence of situations with legal implications. Dealing with large volumes of pPCIs during night shift requires an adequate number of healthcare providers to take on the unit activity scheduled for the next day. Both the design and makeup of the personnel of infarction centers should take this matter into serious consideration. Without an appropriate sizing of the personnel involved, staff will often have to perform elective procedures deprived of sleep and without the adequate resting time. These procedures have been associated with a higher number of suboptimal results,38 which may have legal consequences for the healthcare providers due to civil liability insurance limitations. If the pPCI procedures are performed during the night shift, an 8-hour resting period after the procedure seems like a reasonable amount of time before the staff goes back to their daily routine.

Also due to the fast action required the peculiarities of pPCI for the management of STEMI often puts a lot of stress on the healthcare providers, because of the complexity of the procedure, and the risk of complications for the patients, all of it due to the procedure per se or due to morbimortality. The variability of schedules, the required urgent action, and the immediate availability of the personnel involved determine a very particular type of “availability”. This may contribute to the higher incidence of the so-called burnout syndrome, depression and anxiety among the staff under high healthcare and emotional pressure as experienced in the cath lab.39 Added to this, there is the high incidence of trauma problems interventional cardiologists suffer39 and, in the long run and with a stochastic component, the possibility of developping certain types of neoplasms.40

In this context it should be mentioned that many pPCI programs in Spain are not categorized as individual specialty programs. Therefore, the financial retributions to these healthcare providers are no different from the retributions of other providers dealing with urgent interventions of lower complexity less frequently, in low or no risk patients and that can often be scheduled several hours in advance. All these aspects are perceived by interventional cardiologists as a mismatch that goes against their best interest. In Spain this is specifically seen in transplant programs and is probably one of the reasons that explains the level of excellence that these programs have achieved in this country.

Ignoring all these aspects can be detrimental to the teams and could in fact lead to situations of discouragement among the staff working in some of these programs. This may have negative repercussions in the level of excellence required by pPCI programs, especially taking into consideration the special profile of the patients involved. Recent data indicate that because of this many highly-experienced healthcare providers (who also happen to be those who do better) will leave these programs as soon as they are entitled due to their age. Also, in order to legally request leaving these mandatory programs, they may claim physical or psychological issues, which would be totally justified and easy to accomplish. All of this puts pPCI programs in a situation of great vulnerability.

PROPOSALS TO ENSURE THE SUSTAINABILITY OF pPCI PROGRAMS

Perfectly established subdivisions to reduce any possible delays

The national territory should be subdivided based on the nearness of hospital centers in order to make sure that the management of STEMI patients happens with the lowest possible delays. This subdivision should entertain concepts such as distance and transfer times to infarction centers. Isochrones should identify distance-related delays to these centers and delays affecting the state of communications. Patients who live in distant neighborhoods or with logistics issues should not undergo pPCI procedures within the intervals recommended; instead, they should be treated immediately with fibrinolysis, and then transferred to the corresponding cardiac center.6

Consensus strategies to reduce transfer times

Regardless of the initial level of care when the diagnosis of STEMI is achieved and when the system is activated (whether from private households, the street, primary care center or regional hospital), protocols for the transfer of patients to pPCI centers should be established. Each pPCI center should agree with the MESs and their corresponding reference hospitals on the best possible strategy to reduce the intervals of treatment. The adequate sizing of these may also be necessary to guarantee the level of care required. Agile communication systems with a centralized structure (emergency coordination center), are key if we want to establish the logistics of the entire process.

The MES emergency coordination center should prioritize the transfer of STEMI patients. Communication with the tertiary hospital through internal phone lines should be established to inform on the estimated transfer timeframe and the patient’s clinical state so that the receiving center can adapt its scheduled daily activity to the arrival of this unexpected emergent procedure. All these timeframes should be recorded prospectively to make the corresponding analysis of any delays that may have occurred during the transfer and be able to identify potential room for improvement. These protocols should be reviewed periodically on a result assessment basis.

Adequacy of pPCI-capable infarction centers

The degree of adequacy will depend on the number of pPCIs performed. The scope and benefit of the pPCI to a significant number of STEMI patients requires specific measures that should take into consideration a series of aspects that make it a particularly complex procedure. PPCI centers should be structured, organized, and properly sized to be able to handle significant increases in the number of urgent procedures. These programs should also include the transfer of patients through the entire intrahospital pathway. Several additional resources are necessary with different factors in each and every one of them:

 

 

Priority phone availability versus physical presence

Physical presence of hemodynamics teams to perform pPCIs at the very hospital is an option that has always been entertained, but it is an actual reality in very few hospitals worldwide. The timeframe between activation and the opening of the artery using the appropriate strategy of phone location should not exceed 60 minutes and different studies have found no differences at all when it comes to delays in the provision of adequate care and results regardless of whether the team that performs the intervention is physically stationed at the center or is available through the phone. Additionally, considering an adequate number of interventional cardiologists per center, accredited nurses, and the remaining personnel involved in the program, the activities scheduled for the next day could be compromised if the team on call is physically stationed at the hospital, not if it is available through the phone.

Recognition and the right incentives

It is advisable to give pPCI programs a special status by taking into consideration that we are dealing with professionals with a high level of training who neeed to be available at all time, have an immediate capacity of reaction, and be available on different schedules and all at stressful settings due to the complexity of the procedures performed and the risk involved when managing this type of patients. A similar example of this is the special consideration given today to heart transplant programs.

Mandatory audited registry with periodic comparative analyses

It is essential to keep a mandatory prospective registry that includes patients’ baseline characteristics, those of the infarct, the time elapsed between symptom onset and revascularization, the procedural characteristics and the results obtained, and the patient’s clinical progression until he is discharged from the hospital (including reference centers when transferring patients during the acute phase). Both intervention times and results should be monitored periodically in every center and compared to other centers in order to guarantee the quality of the services provided and, if necessary, make the necessary adjustments. Keeping track of all this through a nationwide, verifiable, and independent registry with public data available of all the existing pPCI programs with results by sectors and centers should be mandatory in our country.

There is this pressing need to know the results of the programs implemented in different AACC. Mortality in STEMI is highly dependent on the quality of care received and comparing results among different countries, AACC and hospitals is not only a need but also an obligation that the Administration and the scientific societies should observe to keep healthcare providers and the population duly informed.

CONFLICTS OF INTEREST

R. Moreno is an Associate Editor of REC: Interventional Cardiology.

REFERENCES