To the Editor,

The percutaneous closure of ventricular septal defect (VSD) is still not widely used today due to its potential complications (atrioventricular block, valvular heart disease, hemolysis), and technical limitations, particularly, in low-weight patients.1

Devices specifically designed for the closure of perimembranous VSD (pmVSD) have an asymmetric design that conditions implantation via antegrade venous access. Therefore, the standard procedure requires creating an arteriovenous loop across the defect to advance the device until its sequential release from the aorta or the left ventricle. An example of this is the Nit-Occlud Lê VSD-Coil device (PFM Medical, Germany) that has a good safety and efficacy profile.2 However, the creation of the loop can be the cause for transient atrioventricular blocks and hemodynamic instability especially in low-weight patients.3

Also, the use of different unspecific occluders—with good clinical outcomes—for this indication has been described, especially if the defect comes with aneurysmal tissue.4 Thanks to their symmetric design and low profile, some devices can be released from the arterial side (retrograde), thus avoiding the creation of the loop. This simplifies the technique, shortens procedural time, and minimizes the dose radiation received by the patient. Such approach has already been described with good clinical outcomes with a specific design for the closure of the VSD, the Konar-MF (Lifetech, China).5 Given these potential benefits, we decided to start using this technique back in September 2019.

Ever since, transarterial retrograde access has been used in 12 out of every 20 patients treated with the percutaneous or posteroperative closure of VSD. This approach became consolidated during the learning curve and ended up being the approach of choice when dealing with favorable anatomies: non-supracristal perimembranous single defects without coronary leaflet prolapse, at least, 3 mm away from the aortic annular plane of < 6 mm in the right entrance and preferably with aneurysmal tissue. Different occluders with symmetric design were used like the ADO II (patient #4; videos 1 and 2 of the supplementary data), the Piccolo (patient #5; videos 3 and 4 of the supplementary data), the ASO (Abbott) or the Konar-MF (patient #10; videos 5 and 6 of the supplementary data). We included the retrograde use of the ADO device (Abbott) in a patient with postoperative residual VSD without aortic edge with good clinical outcomes.

Procedure was scheduled in all the patients and performed under general anesthesia and with mechanical ventilation. Catheterization of the VSD and the right ventricle was performed with a right coronary artery curve catheter and a 0.035 in hydrophilic guidewire. A Teflon-coated exchange guidewire was placed in the right ventricular apex, 1 catheter carrying the device was mounted on it and moved forward. Sequential release started from the right ventricular apex until contacting the defect. Afterwards, the retention body and disc were released while protected by the catheter across the aortic valvular plane. Monitorization during the procedure was performed under echocardiography (transthoracic if < 10 kg, transesophageal in the remaining cases) and angiography guidance through the carrier catheter. Final hemostasis occurred through manual compression.

The patients’ median age and weight were 4 years (2 months to 38 years) and 22.2 kg (2.7-100), respectively. The largest diameter of the defect estimated through transesophageal or transthoracic echocardiography was 4.5 mm (3 mm to 8.4 mm) while the device waist diameter was 5.5 mm (4 mm to 12 mm). The variety of the devices implanted shows the progression of the technology available during the time of the series, and the lack of devices approved for retrograde use until the arrival of the Konar-MF device.

Procedure was successful in all the patients, and immediate total occlusion was achieved in 10 patients. No acute atrioventricular block events were reported. One embolization of the ADO II device to the pulmonary artery was described in the lowest-weight patient because the defect had been initially underestimated; the defect was recaptured and closed with a larger device. Grade II tricuspid valvular disease was described in the same patient immediately after implantation.

The median x-ray image time was 15.3 min [range, 7-32]. No complications associated with arterial access were reported.

The median of follow-up after the procedure was 20 months (2-67). During this time, 3 deaths that were not associated with the procedure whatsoever (table 1). The remaining patients are still being followed without presence of atrioventricular blocks or valvular heart disease. They all keep the full closure of the defect to this date.


Table 1. Patients treated with percutaneous closure of perimembranous ventricular septal defect via retrograde access

Patient Age Weight (kg) Underlying heart disease Indication for closure Diameter of VSD in the LV Echo (mm) Qp/Qs ratio X-ray image time (min) Success Immediate complications Fr Device Device waist Follow-up (m) Complications at follow-up Cause of death
1 26 y 48 pmVSD Postop 8.4 1.4 12.5 Partial No 8 ASO 12 58 No
2 8.4 y 24.5 pmVSD Echo 7 1.4 11.6 Yes No 5 ADO II 5 71 No
3 4.9 y 20.5 pmVSD Echo 4.5 1.5 15.3 Yes No 4 ADO II 4 59 No
4 6 m 2.7 pmVSD Echo 4 3 20.3 Yes Embolization 4 ADO II 4 12 Death LTE in syndromic patient (mucopolysaccharidosis)
5 8 m 5.7 pmVSD Postop 3 1.4 17.8 Yes No 5.5 Piccolo 5 65 Death Refractory pulmonary hypertension in complex heart disease (Shone complex)
6 3.2 y 24 pmVSD Echo 4.5 1.5 10.4 Yes No 6 Piccolo 5 33 No
7 2 m 6 pmVSD Postop 3.3 1.4 31.8 Yes No 4 Piccolo 5 2 Death Postoperative aortitis
8 38 y 100 TOF Postop 7 1.5 16.4 Yes No 8 ADO I 12 51 No
9 12.5 y 36 DCRV Postop 5 1.3 7.1 Yes No 5 Konar 10 11 No
10 2.9 y 18.4 pmVSD Echo 8 1.5 17.2 Yes No 5 Konar 8 11 No
11 2.2 y 13 pmVSD Echo 4 1.5 15.4 Yes No 5 Konar 6 9 No
12 12.6 y 48.5 pmVSD Echo 3.5 2 13.2 Yes No 5 Konar 7 6 No

DCRV, double-chambered right ventricle; Echo, repercussion on echocardiography; Fr, French; kg, kilogram; LTE, limitation of therapeutic effort; LV, left ventricle; m, months; min, minutes; mm, millimeters; pmVSD, perimembranous ventricular septal defect; Postop, postoperative; Qp/Qs ratio, pulmonary flow/systemic flow; TOF, tetralogy of Fallot; VSD, ventricular septal defect; y, years.


This is the first case series ever conducted in Spain of closure of pmVSD via retrograde arterial access with a high rate of success and a low rate of complications.

Different unspecific devices for the closure of pmVSD with symme-tric design (ADO II or Piccolo) or else the new Konar-MF device (figure 1)—specifically approved for this procedure —can be implanted via retrograde arterial access, which simplifies the routine closure technique making it feasible for low-weight children in whom the creation of an arteriovenous loops is associated with a higher risk of hemodynamic instability or transient atrioventricular block. Also, the low profile of the device does not increase the risk of damage to the femoral arterial access compared to the traditional technique. Therefore, we propose this therapeutic alternative in selected patients.


Figure 1. Patient #10. A: Angiography and graphic representation of the Konar-MF device. B: Konar-MF final implantation position.


FUNDING

None whatsoever.

AUTHORS’ CONTRIBUTIONS

A. Rasines Rodríguez, and M. M. Aristoy Zabaleta: data curation, analysis, bibliographic search, and drafting of the manuscript. C. Abelleira Pardeiro: original idea, involved with the patient healthcare process, work supervision, data curation, analysis, and drafting of the manuscript. E. J. Balbacid Domingo: work creation and supervision, and directly involved with the patient’s healthcare process. S. Jiménez Valero, and F. Gutiérrez-Larraya Aguado: patient care, and critical review of the manuscript. All the authors reviewed and approved the manuscript final version.

CONFLICTS OF INTEREST

None reported.

SUPPLEMENTARY DATA



Vídeo 1. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344



Vídeo 2. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344



Vídeo 3. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344



Vídeo 4. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344



Vídeo 5. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344



Vídeo 6. Rasines Rodríguez A. DOI: 10.24875/RECICE.M22000344

REFERENCES

1. Ghosh S, Mukherji A, Chattopadhyay A. Percutaneous closure of moderate to large perimembranous ventricular septal defect in small children using left ventricular mid-cavity approach. Indian Heart J. 2020;72:570-575.

2. Solana-Gracia R, Mendoza Soto A, Carrasco Moreno J, et al. Registro español de cierre percutáneo de comunicación interventricular con dispositivo NitOcclud Lê VSD-Coil. Experiencia tras más de 100 implantes. Rev Esp Cardiol. 2021;74:591-601.

3. Carminati M, Butera G, Chessa M, et al. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J. 2007;28:2361-2368.

4. Cinteza˘ E, Butera G. Complex ventricular septal defects. Update on percutaneous closure. Rom J Morphol Embryol. 2016;57:1195-1205.

5. Haddad R, Daou L, Saliba Z. Percutaneous closure of restrictive‐type perimembranous ventricular septal defect using the new KONAR multifunctional occluder: Midterm outcomes of the first middle‐eastern experience. Catheter Cardiovasc Interv. 2019;96:E295-E302.

* Corresponding author.

E-mail address: alejandro.rasines@gmail.com (A. Rasines Rodríguez).

To the Editor,

Transcatheter aortic valve implantation (TAVI) is a therapeutic alternative that has proven safe and effective across different clinical settings. Over the last few years, more and more cases of «emergency TAVI» have been reported.1-2 Currently, this term is often used for those implantation procedures performed during admission due to decompensated heart failure although this concept includes very different situations. The therapeutic option to treat cardiogenic shock should be «emergency TAVI», that is, implantation performed within the first 72 hours after admission.3 This is the case of a patient with severe aortic stenosis who was transferred to our center with signs of cardiogenic shock.

This is the case of a 67-year-old man. The patient was a former smoker and a regular drinker. Initially, he had been admitted to a different center with early signs of heart failure. Arterial pressure at admission was 120/90 mmHg with global congestion and need for low-flow oxygen therapy. Diuretic treatment was started, and the echocardiogram revealed the presence of severe aortic stenosis with left systolic dysfunction. The patient had signs of liver (alanine aminotransferase, aspartate aminotransferase, and bilirubin levels of 1244 u/L, 1808 u/L, and 2 mg/dL, respectively, and normalized international ratio of 2), and renal failure (creatinine levels of 2.01 mg/dL), and arterial lactate levels of 2.8 mmol/L. Cardiac markers were high (N-terminal B-type natriuretic propeptide, and high-sensitivity troponin I levels of 6753 pg/mL, and 468-450 ng/mL, respectively). Given the progressive worsening of the patient, transfer to our center cardiac surgery intensive care unit was decided. After the patient’s arrival, cardiac catheterization was performed with a Swan-Ganz catheter. It revealed:

  • – Pulmonary artery and aortic saturation of 56% and 98%, respectively (nasal cannula at 2L).
  • – Pressure: right atrium, 16 mmHg; pulmonary artery, 55/35/42 mmHg; pulmonary capillary wedge pressure, 32 mmHg; aorta, 110/80/90 mmHg.
  • – Cardiac output (thermodilution): 2.8 L/min.

The echocardiogram confirmed the presence of a left ventricular ejection fraction of 10% with moderate mitral regurgitation (video 1 of the supplementary data) and severe aortic stenosis (figure 1A). The levels of arterial lactate upon the patient’s arrival were 3.6 mmol/L. Given the situation of normotensive cardiogenic shock, inotropic treatment with dobutamine (up to 12 mcg/kg/min) was initiated. It improved cardiac index up to 2.2 L/min/m2 and brought lactate levels back to normal within the first 8 hours after admission. A computed axial tomography (that same afternoon) and coronary angiography (the next morning, figure 1B) were performed. The screening results obtained were favorable for transcatheter aortic valve implantation:

  • – Tricuspid aortic valve. Coronary artery calcium score, 2100.
  • – Aortic annulus: perimeter, 88 mm; area, 556 mm2.
  • – Sinus segment: 35 mm x 33 mm x 33 mm.
  • – Distance between annulus and left main coronary artery: 11 mm; to right coronary artery, 17 mm.
  • – Significant lesion to the ostial left anterior descending coronary artery with distal TIMI-grade 3 flow (Thrombolysis in Myocardial Infarction) and no data suggestive of complications. Chronic total coronary occlusion of right coronary artery.
  • – Calcified femoral accesses without significant lesions and proper caliber.

Figure 1. A: continuous-wave Doppler echocardiography at aortic valve level. B: femoral angiography. C: significant lesion to the ostial left anterior descending coronary artery with distal TIMI-grade 3 flow and no data suggestive of complications. D: chronic total coronary occlusion of right coronary artery.


When multi-organ failure recovered, and hemodynamic data collected with the Swan-Ganz catheter came back to normal, the heart team recommended «emergency TAVI» given the situation of cardiogenic shock, and management of coronary artery disease was deferred and treated in a second surgical act.

The patient was intubated before the procedure. After predilatation with a 25 mm balloon, a 34 mm Evolut PRO valve (Medtronic, United States) was implanted via left femoral artery in the cusp-overlap view to optimize commissural alignment and minimize damage to the conduction system. Final outcomes were excellent without gradient or residual aortic regurgitation. The patient showed transient left bundle branch block, which is why atrial pacing stress echocardiography was conducted that did not reach the Wenckebach point at 130 beats per minute, which is why the electrocatheter was eventually removed. Left femoral artery was closed with 2 Perclose Proglide sutures as the good results seen on the angiography confirmed (video 2 of the supplementary data). Hemodynamic improvement was immediate. The patient was progressively weaned off dobutamine and extubated early. Prognostic benefit treatment was optimized, and the cardiac magnetic resonance imaging showed a left ventricular ejection fraction of 28% with viability in the entire myocardium. The patient was discharged 2 weeks after admission for close follow-up, and to plan outpatient coronary revascularization.

This case exemplifies the delicate balance between the time when the cause for the shock was corrected and the hemodynamic stabilization and optimization of organ perfusion was achieved. A recent review and meta-analysis found no differences whatsoever between emergency and elective implantation. However, the rate of acute kidney injury was higher3; due to the severity of these patients, the 1-month mortality rate after emergency implantation is twice as high compared to elective implantation (8.8% vs 4.4%). If only patients with cardiogenic shock are considered, the 1-month mortality rate is higher (11.8% up to 33.3%).4-5 In conclusion, we believe that «emergency TAVI» is a therapeutic alternative associated with good clinical outcomes.

FUNDING

None whatsoever.

AUTHORS’ CONTRIBUTIONS

Manuscript drafting: J. García-Carreño, I. Sousa-Casasnovas, J. Martínez-Solano, J. Elízaga-Corrales, F. Fernández-Avilés, and M. Martínez-Sellés. Image and video aquisition: J. García-Carreño, and J. Martínez-Solano. F. Fernández-Avilés, and M. Martínez-Sellés contributed to this article similarly.

CONFLICTS OF INTEREST

None reported.

SUPPLEMENTARY DATA



Vídeo 1. García-Carreño J. DOI: 10.24875/RECICE.M22000336



Vídeo 2. García-Carreño J. DOI: 10.24875/RECICE.M22000336

REFERENCES

1. Kolte D, Khera S, Vemulapalli S, et al. Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Inisights From the STS/ACC TVT Registry. JACC Cardiovasc Interv. 2018;11:1175-1185.

2. Elbadawi A, Elgendy IW, Mentias A, et al. Outcomes of urgent versus nonurgent transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020;96:189-195.

3. Aparisi A, Santos-Martínez S, Delgado-Arana JR, et al. Resultados del TAVI emergente comparado con el procedimiento electivo: metanálisis. REC Interv Cariol. 2021;3:166-174.

4. Fraccaro C, Tekes RC, Tchétché D, et al. Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry adults. Catheter Cardiovasc Interv. 2020;96:1128-1135.

5. Frerker C, Schewel J, Schlüter M, et al. Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis. Eurointervention. 2016;11:1530-1536.

* Corresponding author.

E-mail address: jgc.fire@gmail.com (J. García-Carreño).

To the Editor,

This is the case of a young man with a postmyocardial infarction large ventricular septal defect (VSD) surgically repaired 10 days after venoarterial extracorporeal membrane oxygenation (VA-ECMO) therapy. The patient still had a large residual VSD that triggered a situation of refractory congestion due to pulmonary hyperflow that was successfully treated with percutaneous closure. The patient gave his informed consent so this case could be published anonymously.

This is the case of a 46-year-old man without a past medical history and inferior wall myoscardial infarction and Killip class I. Cardiac catheterization confirmed the presence of multivessel disease. The culprit lesion found at the proximal right coronary artery [TIMI grade-0 flow (Thrombolysis in Myocardial Infarction)] was revascularized with a drug-eluting stent. The patient was admitted to the coronary care unit, and progressed into cardiogenic shock. Several transthoracic and transesophageal echocardiographic studies revealed the presence of severe biventricular dysfunction and a large, basal inferoseptal VSD (50 mm) of anfractuous non-restrictive trajectory (Qp/Qs ratio of 3) (figure 1).


Figure 1. Large inferoseptal ventricular septal defect up to the apical segments as seen on the transthoracic echocardiography (A) with a 50 mm maximum diameter as seen on the transesophageal echocardiography. (B) The long (C) and short (D) axes seen on the transesophageal echocardiography reveal the presence of a non-restrictive left-to-right shunt.


The patient was intubated, treated with VA-ECMO and with an intra-aortic balloon pump. He required amines with fast stabilization. Direct heart transplantation was suggested due to the high surgical risk involved, but eventually delayed surgical repair was used.

The patient remained stable and without heart failure. After 9 days, he showed signs of hemolysis due to thrombosis of the ECMO filter with acute kidney injury and pulmonary edema that required continuous venovenous hemodiafiltration. Emergency surgery was decided with double coronary artery bypass graft and VSD closure with a pericardial surgical patch. The patient entered a state of deep shock due to severe ventricular dysfunction (left ventricular ejection fraction < 10%) during postoperative period. Afterwards, the patient improved gradually with decannulation and extubation 5 and 7 days, respectively after the procedure.

The patient showed pulmonary congestion and required venovenous hemodiafiltration followed by IV diuretics. The transthoracic and transesophageal echocardiographic follow-up studies confirmed the presence of a novel non-restrictive residual VSD. After a negative fluid balance, cardiac catheterization revealed these values: aortic pressure, 90/60 mmHg; pulmonary arterial pressure, 26/16/8 mmHg; pulmonary capillary wedge pressure; 7 mmHg, right atrial pressure, 4 mmHg, and a Qp/Qs ratio of 1.7.

Given the presence of residual VSD with congestion due to hyperflow, closure was indicated. Due to the high surgical risk involved (myopathy, renal failure, ventricular dysfunction), the percutaneous approach was used. VSD was closed via femoral vein using a 12 mm Amplatzer AVPII device (Abbott, United States) that resulted in the overt reduction of the angiographic shunt with a restrictive intra-device residual shunt (figure 2).


Figure 2. Postoperative non-restrictive residual ventricular septal defect, (A) and presence of a small residual ventricular septal defect after closure with the Amplatzer device (B) as seen on the transthoracic echocardiography. Angiography shows the presence of a significant left-to-right shunt (C) significantly reduced after percutaneous closure (E) with an Amplatzer-AVPII device (D).


Venovenous hemodiafiltration and diuretics were removed after closure. Neurohormonal blockade was initiated, and the patient was discharged from the hospital after achieving euvolemic state with good functional class.

Postmyocardial infarction VSD is a rare mechanical complication. Its incidence rate has dropped (1%-3% down to 0.1%-0.3%) in the era of percutaneous revascularization. It often appears 3 to 5 days after infarction although it can occur within the first 24 hours or later. In the anterior acute myocardial infarction setting, VSD is often apical and has a simple trajectory. In the inferior wall acute myocardial infarction setting, however, VSD is often basal, large, and has an anfractuous and non-restrictive trajectory with worse prognosis due to the presence of a larger shunt and right ventricular damage. Definitive treatment is surgical repair, but it has a high mortality rate (up to 40%). The best time to perform surgery is still controversial: clinical practice guidelines recommend emergency surgery. However, experienced centers prefer delayed surgeries when the appearance of scar tissue allows proper suture.1 In the series published, the mortality rate associated with early surgeries is higher compared to delayed surgeries beyond the first week. However, selection bias can occur since the most severe patients are operated on early. While waiting, the use of mechanical support devices can prevent hemodynamic deterioration.2 However, the risk of complications associated with treatment is higher with longer waiting times. Regarding the device that should be selected, evidence here is based on small observational studies. Intra-aortic balloon pump can be an option, but it is insufficient in the presence of established shock; the Impella device (Abiomed, United States) allows proper left ventricular discharge. Setback here is the possibility of reversing the shunt causing arterial desaturation. VA-ECMO has been successfully used and reverses the situation of shock as a bridging therapy to surgery or, in cases of very large VSD, as a bridging therapy to heart trasplantation.3 Total artificial heart has also been used in this setting yet experience is limited on this regard. In experimental models no device has been able to normalize the hemodynamic situation or balance the Qp/Qs ratio. However, it seems that the combination of VA-ECMO plus Impella/intra-aortic balloon pump is the most favorable option.4 A special situation is the presence of pulmonary edema due to pulmonary hyperflow following left-to-right shunt. It looks like optimizing the left ventricular discharge could improve this situation by reducing the Qp/Qs ratio. However, management is still controversial. We have been gaining experience with percutaneous closure and it has been used as the definitive treatment in the management of small VSDs, and as a bridging therapy to surgery with larger VSDs although with risk of failure and embolization involved. Its use has also been reported in residual VSDs after cardiac surgery.5

In conclusion, the management of postmyocardial infarction VSD is controversial. Surgery is the treatment of choice, and it seems like delaying surgery increases the chances of success. However, the optimal waiting time is still unknown. The use of mechanical support can prevent hemodynamic deterioration being VA-ECMO an attractive therapeutic option. Percutaneous closure can be an alternative in certain settings. Finally, evidence on this regard is scarce and based on observational studies only and questions still abound.

FUNDING

None whatsoever.

AUTHORS’ CONTRIBUTIONS

All the authors made their contributions during the patient’s entire healthcare process while drafting and reviewing the case.

CONFLICTS OF INTEREST

None reported.

REFERENCES

1. Ronco D, Matteucci M, Kowalewski M, et al. Surgical Treatment of Postinfarction Ventricular Septal Rupture. JAMA Netw Open. 2021;4:e2128309.

2. Hussain S, Pillarella J, Pauwaa S, et al. Management of Post Infarction Ventricular Septal Rupture in Contemporary Era. J Card Fail. 2020;26(10 Suppl):S106.

3. Rob D, Špunda R, Lindner J, et al. A rationale for early extracorporeal membrane oxygenation in patients with postinfarction ventricular septal rupture complicated by cardiogenic shock. Eur J Heart Fail. 2017;19:97-103.

4. Pahuja M, Schrage B, Westermann D, Basir MB, Reshad Garan A, Burkhoff D. Hemodynamic effects of mechanical circulatory support devices in ventricular septal defect. Circ Heart Fail. 2019;12:e005981.

5. Faccini A, Butera G. Techniques, Timing, and Prognosis of Transcatheter Post Myocardial Infarction Ventricular Septal Defect Repair. Curr Cardiol Rep. 2019;21:59.

* Corresponding author.

E-mail address: jazpirozfranch@gmail.com (M.J. Azpiroz Franch).

Twitter Autor: jaimeaboal

To the Editor,

The use of new technologies applied to cardiology has proven effective for the patients’ clinical improvement,1 especially in certain situations like arrhythmias, heart failure or secondary prevention.2,3

In particular, the use of smartphones applied to the healthcare networks of patients with ST-segment elevation acute myocardial infarction (STEMI) is effective to share electrocardiographic tracing and improve the coordination of the different healthcare workers involved in the management of the patients. The result is shorter primary angioplasty times.4,5

This scientific letter discusses the results of a pilot test on the working of an application for both tablets and smartphones (ODISEA APP [Myocardial Infarction Safety Transfer]) built to improve the healthcare networks of patients with STEMI (figure 1).


Figure 1. Screenshots from the ODISEA APP. Geolocation, data on transfer and the infarction including images from the electrocardiogram.


The primary goal of this app is to improve the coordination of the healthcare personnel involved in the management of patients with STEMI who require transfer to a PCI-capable center. This improvement should shorten primary angioplasty times and avoid unnecessary transfers. Other goals are to increase patient safety (by registering the medication administered, giving recommendations to the primary care physician, discussing doubts, etc…), improve coordination at the cath lab with elective cases, prepare, in advance, the material needed, and improve the patient’s location after the primary angioplasty.

This is how the app works: when a patient with STEMI is first helped by a primary care physician, a non-PCI-capable emergency doctor or the doctor from the emergency medical team (EMT) in the house or on the street, the app is opened with a smartphone/table using the healthcare worker’s identification and working station. Afterwards, a short questionnaire is rapidly filled out with data from the patient and the infarction. The electrocardiogram tracing is added using the camera on the smartphone or the table.

The app sends a warning message with this information to the devices the EMT physicians carry, both to coordination and to the mobile units close to the patient and the PCI-capable reference hospital cardiology personnel (interventional cardiologist, cardiologist on call, interventional cardiology nurse, and nursing team at the cardiac surgery intensive care unit).

Based on the data entered the app:

  • – Creates an estimate time of diagnostic electrocardiogram-guidewire passage.6
  • – Makes suggestions on the most adequate medical management and treatment for the patient (antiplatelet, anticoagulation therapy).
  • – Opens a chat so the primary care physician can clear up doubts and agree on the best possible treatment with EMT physicians, the cardiologist on call, and the interventional cardiologists involved. All of them have access, in real time, to the information registered: data on the patient and the infarction sustained, electrocardiogram records, treatment administered, serious complications, etc.

If transfer for primary angioplasty is activated, the geolocation of the patient is started on the device of the EMT physician doing the transfer. From that moment onwards, the entire healthcare personnel involved can follow, in real time, the transfer of the patient to the PCI-capable hospital. The interventional cardiology unit can coordinate more precisely the elective activity of each cath lab available with up-to-the-minute information on the patient’s exact location. Also, by activating a warning message on the estimated time of arrival.

The medication administered, and serious complications reported moments before the patient gets to the cath lab are recorded.

The patient gets to the reference hospital cath lab on a treatment agreed by the entire healthcare personnel after solving all possible doubts, with all the relevant information previously known, and in perfect coordination with the entire team.

Finally, the interventional cardiologist performing the primary angioplasty adds information confirming, or not, the «Infarction Code», the angiographic result, the patient’s clinical status, the primary angioplasty times, the complications reported during the procedure, and information on the unit the patient is being transferred to. Afterwards, the case is eventually closed.

A final report is, then, created with a summary including all the data entered throughout the process that is sent to all the healthcare workers involved (primary care physician, EMT, cardiologist on call, and interventional cardiologist), which improves positive feedback.

This app has been designed in observance of all data confidentiality rules and regulations, with an obligation to authenticate, and with safe servers for data collection in full compliance with the General Data Protection Regulation (GDPR).

A pilot test was run with this app between September 2021 and January 2022. A total of 227 STEMIs transferred for primary angioplasty were included (in 98 cases the ODISEA APP was used as opposed to 129 where it wasn’t). A summary of results is shown on table 1. No significant differences were reported between both groups regarding the patient’s past medical history, the infarction location, the Killip grade or the place where the first medical contact occurred. Statistically speaking, patients treated with the ODISEA APP were further away from the PCI-capable center. A non-significant tendency was seen towards shorter primary angioplasty times (diagnostic electrocardiogram-guidewire passage) in the ODISEA compared to the NON ODISEA group (112 min vs 122 min; P = .3), a non-significant reduction of cases with times > 120 min (26.2% vs 35.7%, respectively; P = .1), and a tendency towards fewer cases eventually diagnosed as non-acute coronary syndrome (7.1% vs 13.2%; P = .1).


Table 1. Comparative summary of patients from the ODISEA APP pilot test

ODISEA (98 patients) NON ODISEA (129 patients) P
Age (mean, SD) 61 (13.9) 63 (13.1) .1
Women, n (%) 21 (21.4%) 32 (24.8%) .5
Smoking, n (%) 44 (44.9%) 50 (38.8%) .3
Arterial hypertension, n (%) 48 (49%) 59 (45.7%) .6
Dyslipidemia, n (%) 34 (34.7%) 54 (41.9%) .2
Diabetes mellitus, n (%) 18 (18.4%) 31(24%) .3
Previous AMI, n (%) 16 (16.3%) 16 (12.4%) .4
Previous heart surgery, n (%) 3 (2.1%) 2 (1.6%) .4
Anterior location, n (%) 39 (39.8%) 43 (33.3%) .3
Killip grade > 2, n (%) 5 (5.1%) 8 (6.2%) .7
Location of the first medical contact .5
 EMT, n (%) 35 (35.7%) 39 (30.2%)
 Outpatient, n (%) 28 (28.6%) 36 (27.9%)
 Non-PCI-capable hospital, n (%) 35 (35.7%) 54 (41.9%)
Distance in km, mean (SD) 42 (19.3) 36 (21.7) .02
Sudden death, n (%) 1 (1%) 1(0.8%) .8
Diagnostic ECG-guidewire passage time in min, mean (SD) 112 (28) 122 (24) .3
Patients with diagnostic ECG-guidewire passage time > 120 min, % 26.2% 35.7% .1
Diagnostic ECG-start of transfer time in min, mean (SD) 32 (8) 36 (10) .5
Transfer time until arrival at the cath lab in min, mean (SD) 67 (21) 70 (19) .6
Cath lab-guidewire passage time in min, mean (SD) 17 (7) 19 (6) .5
AMI CODE not properly indicated, n (%) 7 (7.1%) 17 (13.2%) .1

AMI, acute myocardial infarction; ECG, electrocardiogram; EMT, emergency medical team; SD, standard deviation.


Finally, we should mention that this app has been created by a working group including EMT physicians, primary care practitioners, doctors from non-PCI-capable hospitals, interventional cardiologists, and cardiologists from cardiac surgery intensive care units.

FUNDING

Grants from the following organizations were received: Catalan Society of Cardiology: Research Projects 2022, and Spanish Society of Cardiology: Research training of the ischemic heart diseases and cardiology critical care section.

AUTHORS’ CONTRIBUTIONS

All the authors contributed to the development of this application and drafted the manuscript.

CONFLICTS OF INTEREST

None whatsoever.

REFERENCES

1. Nguyen HH, Silva JNA. Use of smartphone technology in cardiology. Trends Cardiovasc Med. 2016;26:376–386.

2. Hamilton SJ, Mills B, Birch EM, Thompson SC. Smartphones in the secondary prevention of cardiovascular disease: a systematic review. BMC Cardiovasc Disord. 2018;18:25.

3. Kotecha D, Chua WWL, Fabr/itz L, et al; European Society of Cardiology (ESC) Atrial Fibr/illation Guidelines Taskforce, the CATCH ME consortium and the European Heart Rhythm Association (EHRA). European Society of Cardiology smartphone and tablet applications for patients with atrial fibr/illation and their health care providers. Europace. 2018;20:225–233.

4. Chao C-C, Chen Y-C, Shih C-M, et al. Smartphone transmission of electrocardiography images to reduce time of cardiac catheterization laboratory activation. J Chin Med Assoc JCMA. 2018;81:505–510.

5. Park JJ, Yoon C-H, Suh J-W, et al. Reduction of Ischemic Time for Transferred STEMI Patients Using a Smartphone Social Network System. J Am Coll Cardiol. 2016;68:1490–1492.

6. Aboal J. Creación y validación de un modelo de predicción para el cálculo del tiempo de angioplastia primaria en pacientes con infarto agudo de miocardio que son trasladados a un hospital con disponibilidad de hemodinámica. Tesis doctoral inédita. Universidad de Girona. Departamento de ciencias médicas. 2020. Available online: http://hdl.handle.net/10803/669976. Acceso 15 Jul 2022.

* Corrresponding author.

E-mail address: jaimeaboal@gmail.com (J. Aboal).

  @jaimeaboal

Twitter Autor: ignamatsant

To the Editor,

A novel aspect of medical imaging visualization are the so-called extended realities, a term that includes a plethora of very different technologies such as virtual, augmented, and mixed reality. The latter being the most recent one of all. The ultimate feature of mixed reality headsets is their capacity to perceive the real world while mixing virtual models to complement the sources of information traditionally available. In principle, there are multiple possible applications to the medical field being particularly interesting their integration into surgical and interventional procedures. Currently, the main limitation preventing their clinical applicability is that no commercial applications remain available in the market for users. Also that, for every specific new case, specific solutions need to be developed.

In the context of the «3D Augmented Reality Cath Lab» research project (the HAMMOND project) only 1 preliminary clinical experience integrating the mixed reality HoloLens 2 headset (Microsoft, United States) has taken place (figure 1) in the percutaneous coronary intervention setting. Prior to the research ethics committee approval (CASVE-PI-GR-20-2001) a mixed reality application was developed for cardiac catheterization care that was tried in 9 patients treated with transcatheter aortic valve implantation (TAVI).


Figure 1. HoloLens extended mixed reality headset 2.


The descriptive results of this early experience with mixed reality in the different stages of TAVI procedures—shown on figure 1 and video 1 of the supplementary data—follow next:

  • – Vascular puncture guidance support: holograms with echocardiogram imaging were generated in real time (figure 2A). Therefore, through the creation of large virtual «screens» with better ergonomics the operator can visualize both his hands and the imaging support simultaneously. The fine resolution and little latency of the system used allowed us to gain ultrasound-guided arterial access as seen on the HoloLens 2 headset in 5 consecutive cases. Room for improvement has been identified and is in the pipeline right now: the integration of the ultrasound image acquired with the ultrasound probe in such a way that the holograms would be visualized in the «real» position towards the inside of the patient (figure 2B). Currently, several early experiences have been reported with this type of integration1 like hologram-guided punctures mixed with computed tomography (CT) images. The use of holograms from CT generated organs overlapping the patient’s real anatomy has been reported allowing us to simplify complex vascular procedures.2
  • – Interaction with CT generated images in conditions of asepsis: the capacity of augmented reality headsets to be used via voice commands or the user’s own hands (as seen on video 1 of the supplementary data) allows the operator to check different sources of information without losing sterility or interfering with the procedure. Figure 2C and video 1 of the supplementary data exemplify this application with the intraoperative examination of the patient’s CT scan of using the 3mensio Structural Heart software (Pie medical imaging, The Netherlands).
  • – Remote procedural supervision: remote mentoring has proven an extremely useful imaging modality during the COVID-19 pandemic.3,4 In our own single experience with 9 cases including 4 transcatheter aortic valve implantation procedures, 3 bicaval valve implantation procedures for tricuspid regurgitation, and 2 chronic total coronary occlusions, the images and the sound captured by the HoloLens 2 headset can be remotely transmitted to the expert in real time. Therefore, he can not only see the x-ray and the ultrasound images as it is the case with conventional remote mentoring (teleconference), but also the operator’s point of view. Also, the mentor can control the information available through the virtual windows that the operator can see life, for instance, the CT working station. Alternatively, different solutions of telepresence and remote communication have become available like the Mesh software (Microsoft, United States) that allow the operator to visualize the mentor as a real-time hologram (figure 2D).

Figure 2. A: vascular ultrasound integration during puncture. B: schematic representation of simultaneous integration in vascular puncture.1 C: image from the software analysis of the manageable computed tomography scan in conditions of asepsis; D: remote mentoring simulation.


Mixed reality-based technology is giving its first early steps regarding surgical and interventional procedures. Our early experience shows—using scientific methodology—the current actual clinical experience applied to TAVI procedures beyond the future potential benefits of this technology.

The limitations identified when implementing this technology in the interventional cardiology field are basically the complexity associated with the process of integrating hologram-like real-time ultrasound images into the patient’s anatomical structures. Improving this aspect requires better software (by developing applications specifically designed for the use this technology in the interventional cardiology field) and hardware (to facilitate the spatial location of both holograms and patients).

In conclusion, mixed reality can improve the integration of different imaging modalities while performing cardiovascular procedures on our patients. Also, it allows the operator to focus on a single working site, which has the potential of improving the patient’s safety parameters. Thanks to these advantages and the fact that technology has finally reached its maturity at an affordable cost, the continuity of this line of work could be crucial to push interventional cardiology into the future.

FUNDING

The HAMMOND project received a grant from Castille and León Regional Health Authority (GRS 2275/A/2020), and Instituto de Salud Carlos III (DTS21/00158).

AUTHORS’ CONTRIBUTIONS

A. Redondo, and I.J. Amat-Santos contributed substantially to the study design, data curation, analysis or interpretation. C. Baldrón, and J.M. Aguiar contributed to the study design, data curation and interpretation. J.R. González Juanatey, and A. San Román gave their final approval. All the authors performed a critical review of the manuscript intellectual content, and take full responsibility for the accuracy and truthfulness of the study.

CONFLICTS OF INTEREST

None whatsoever.

SUPPLEMENTARY DATA



Vídeo 1. Amat-Santos IJ. DOI: 10.24875/RECICE.M22000322

REFERENCES

1. Nguyen T, Plishker W, Matisoff A, Sharma K, Shekhar R. HoloUS: Augmented reality visualization of live ultrasound images using HoloLens for ultrasound-guided procedures. Int J Comput Assist Radiol Surg. 2022;
17:385-391.

2. Pratt P, Ives M, Lawton G, et al. Through the HoloLens™ looking glass: augmented reality for extremity reconstruction surgery using 3D vascular models with perforating vessels. Eur Radiol Exp. 2018;2:2.

3. Arslan F, Gerckens U. Virtual support for remote proctoring in TAVR during COVID-19. Catheter Cardiovasc Interv. 2021;98:E733-E736.

4. Mahajan AP, Inniss DA, Benedict MD, et al. International Mixed Reality Immersive Experience: Approach via Surgical Grand Rounds. J Am Coll Surg. 2022;234:25-31.

* Corresponding author.

E-mail address: ijamat@gmail.com (I.J. Amat Santos).

  @ignamatsant

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